U.S. patent application number 17/371915 was filed with the patent office on 2021-10-28 for diametric expansion features for prosthetic valves.
The applicant listed for this patent is W. L. Gore & Associates, Inc.. Invention is credited to Kyle W. Colavito, Dustin V. Dienno, Paul D. Goodman, Brandon C. Hedberg, Brandon A. Lurie, Devin M. Nelson.
Application Number | 20210330457 17/371915 |
Document ID | / |
Family ID | 1000005708637 |
Filed Date | 2021-10-28 |
United States Patent
Application |
20210330457 |
Kind Code |
A1 |
Colavito; Kyle W. ; et
al. |
October 28, 2021 |
DIAMETRIC EXPANSION FEATURES FOR PROSTHETIC VALVES
Abstract
Various features and associated advantages are described for
diametrically adjustable support structures, adjustable valve
structures, removable/replaceable valve structures, and associated
systems and methods. Although some examples are directed toward
prosthetic valve that is a conduit having a valve structure, or a
"valved conduit" (e.g., used to replace a pulmonary valve and a
portion of the corresponding pulmonary artery or an aortic valve
and the aortic root), and other examples are directed toward
prosthetic valves implanted native valve orifices (e.g., to replace
an aortic or mitral valve), the features and advantages of the
structures associated with those examples are interchangeable
regardless of a particular application for which the examples are
described.
Inventors: |
Colavito; Kyle W.;
(Flagstaff, AZ) ; Dienno; Dustin V.; (Flagstaff,
AZ) ; Goodman; Paul D.; (Flagstaff, AZ) ;
Hedberg; Brandon C.; (Flagstaff, AZ) ; Lurie; Brandon
A.; (Flagstaff, AZ) ; Nelson; Devin M.;
(Flagstaff, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
W. L. Gore & Associates, Inc. |
Newark |
DE |
US |
|
|
Family ID: |
1000005708637 |
Appl. No.: |
17/371915 |
Filed: |
July 9, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
16355515 |
Mar 15, 2019 |
11071626 |
|
|
17371915 |
|
|
|
|
62644156 |
Mar 16, 2018 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
F16K 15/147 20130101;
A61F 2/2412 20130101; A61F 2250/0082 20130101; A61F 2/2475
20130101; A61F 2/2415 20130101; A61F 2/2418 20130101; A61F
2250/0071 20130101; A61F 2250/001 20130101; A61F 2240/001
20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24; F16K 15/14 20060101 F16K015/14 |
Claims
1. A prosthetic valve, comprising: a diametrically adjustable frame
comprising a plurality of frame elements slidably engaged with one
another; and a plurality of leaflets coupled to the diametrically
adjustable frame, each of the leaflets being secured to a
respective one of the frame elements such that stored leaflet
material is stored in an inactive state when the adjustable frame
is at a first diameter at which the prosthetic valve is configured
to be implanted, each of the leaflets defining a first active size
at the first diameter such that the leaflets allow fluid flow
through the prosthetic valve in a first direction and inhibit fluid
flow through the prosthetic valve in an opposite, second direction,
the adjustable frame being transitionable to a second diameter that
is larger than the first diameter by sliding the plurality of frame
elements relative to one another to diametrically enlarge the
diametrically adjustable frame and such that the stored leaflet
material is paid out to enlarge the active size of the each of the
leaflets to a second active size as the adjustable frame is
diametrically enlarged to the second diameter, and such that each
of the leaflets allow fluid flow through the prosthetic valve in
the first direction and inhibit fluid flow through the prosthetic
valve in the opposite, second direction at the second active
size.
2. The prosthetic valve of claim 1, wherein each of the plurality
of frame elements include tabs for slidably engaging another one of
the plurality of frame elements.
3. The prosthetic valve of claim 1, wherein each of the frame
elements includes a top rail, a bottom rail, a leaflet payout edge
support, a primary leaflet edge support and a secondary leaflet
edge support.
4. The prosthetic valve of claim 3, wherein each leaflet is secured
to a corresponding one of the plurality frame elements, where each
leaflet is secured to the leaflet payout edge support and the
primary leaflet edge support of the corresponding one of the
plurality of frame elements such that the primary leaflet edge
support of the corresponding one of the plurality of frame elements
serves to define a first operative edge of the leaflet and the
secondary leaflet edge support of another one of the plurality of
frame elements serves to define a second operative edge of the
leaflet that is opposite the first operative edge of the
leaflet.
5. The prosthetic valve of claim 1, wherein the frame elements are
axi-symmetric.
6. The prosthetic valve of claim 1, wherein the diametrically
adjustable frame includes retaining features configured act as
stops that limit relative sliding of the plurality of frame
elements at one or more pre-selected diameters of the adjustable
frame.
7. A prosthetic valve, comprising: a first diametrically adjustable
frame element configured to support a valve structure; and a second
diametrically adjustable frame element coupled to the first
diametrically adjustable frame element, the second diametrically
adjustable frame element including a selective expansion feature
for reinforcement of the first diametrically adjustable frame
element against compression at a first diameter at which the
prosthetic valve is configured to be implanted and reinforcement of
the first diametrically adjustable frame element against
compression following diametric expansion of the first frame
element to a second diameter that is larger than the first
diameter.
8. The prosthetic valve of claim 7, wherein the selective expansion
feature is configured to self-engage upon compression at the first
diameter.
9. The prosthetic valve of claim 7, wherein the selective expansion
feature has an undulating shape at the first diameter and more
straight, less undulating shape at the second diameter.
10. A prosthetic valve, comprising: a smaller, first prosthetic
valve having a first inner diameter and including a first support
structure and a first valve structure in an active state such that
the first valve structure is configured to allow fluid flow through
the prosthetic valve in a first direction and inhibit fluid flow
through the prosthetic valve in an opposite, second direction; and
a larger, second prosthetic valve having a second inner diameter
that is larger than the first inner diameter of the smaller, first
prosthetic valve and including a second support structure and a
second valve structure in an inactive state such that the second
valve structure is inoperable to inhibit fluid flow through the
prosthetic valve, wherein the smaller, first prosthetic valve is
releasably secured within the larger, second prosthetic valve such
that the smaller, first prosthetic valve is configured to be
released and removed from the larger, second prosthetic valve to
transition the second valve structure to an active state in which
the second valve structure is configured to allow fluid flow
through the prosthetic valve in the first direction and inhibit
fluid flow through the prosthetic valve in the opposite, second
direction.
11. The prosthetic valve of claim 10, the smaller, first prosthetic
valve is releasably secured within the larger, second prosthetic
valve such that the smaller, first prosthetic valve is configured
to be everted and peeled from within the larger, second prosthetic
valve.
12. The prosthetic valve of claim 10, wherein the larger, second
prosthetic valve includes a support layer and an intermediate layer
disposed inside of the support layer, the intermediate layer being
releasably coupled to the first support structure of the smaller,
first prosthetic valve.
13. The prosthetic valve of claim 12, wherein the intermediate
layer is configured to retain stored portions of the second valve
structure such that the second valve structure is configured to
initially operate at an initial inner diameter that approximates
the first inner diameter of the smaller, first valve.
14. The prosthetic valve of claim 13, wherein the intermediate
layer is compressible and/or removable over time to increase the
initial inner diameter at which the second valve structure operates
to the second inner diameter by releasing the stored portions of
the second valve structure.
15. A method of forming a prosthetic valve that is diametrically
adjustable, the method comprising manufacturing a prosthetic valve
at an initial, maximum diameter with a valve structure of the
prosthetic valve configured to coapt, and then diametrically
compacting the prosthetic valve to a smaller inner diameter at
which the prosthetic valve is configured to be implanted such that
the inner diameter of the prosthetic valve is decreased and
portions of a valve structure of the prosthetic valve are
reversibly attached to an inner surface of the prosthetic valve,
where portions of the valve structure that are unattached to the
inner surface of the prosthetic valve are configured to operatively
coapt at the smaller diameter at which the prosthetic valve is
configured to be implanted.
16. A prosthetic valve comprising: a support structure having an
inflow end and an outflow end, the support structure configured to
be diametrically adjusted from a first diameter at which the
prosthetic valve is configured to be implanted to a second diameter
that is larger than the first diameter, the support structure
including a support portion defining a base, a first leg, a second
leg, a first commissure support, and a second commissure support;
and a valve structure arranged within the support structure and
coupled to the support portion of the support structure, the valve
structure being configured to allow flow in a first direction
through the prosthetic valve while inhibiting flow through the
prosthetic valve in a second direction that is opposite the first
direction when the support structure is at the first diameter and
when the support structure is at the second diameter, the valve
structure including one or more leaflets each having an attachment
zone corresponding to a portion of the leaflet that is coupled to
the support portion of the support structure, each leaflet defining
a base, a free edge, a first commissure region, a second commissure
region, and a belly region, and each leaflet being configured such
that the free edge coapts at both the first diameter and the second
diameter of the support structure.
17. The prosthetic valve of claim 16, wherein each leaflet is
configured with sufficient material in the belly region to
accommodate a reduction in overall height of the valve structure as
the diameter of support structure increases.
18. The prosthetic valve of claim 16, wherein the support structure
further includes a conduit portion, and further wherein the support
portion is more resistant to diametric adjustment than the conduit
portion, such that during diametric adjustment of the support
structure deformation of the support structure occurs
preferentially at the conduit portion.
19. The prosthetic valve of claim 16, wherein the support portion
includes one or more resistant regions and one or more deformation
regions that have relatively decreased resistance to the
deformation regions such that preferential expansion during
diametric adjustment of the support structure occurs preferentially
in the one or more deformation regions of the support portion.
20. The prosthetic valve of claim 19, wherein the one or more
resistant regions are more resistant to creep than the one or more
deformation regions.
21. The prosthetic valve of claim 20, wherein the one or more
resistant regions includes a coating, a surface treatment, a
reinforcement element, or combinations thereof for enhancing
resistance to deformation relative to the one or more deformation
regions.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/355,515, filed Mar. 15, 2019, which claims
the benefit of U.S. Provisional Application No. 62/644,156, filed
Mar. 16, 2018, which are incorporated herein by reference in their
entireties for all purposes.
BACKGROUND
[0002] Prosthetic valves have been developed that attempt to mimic
the function and performance of a native valve. One or more
flexible leaflets are generally coupled to a support structure that
supports the leaflets and provides dimensional stability to the
implanted prosthetic valve.
[0003] In operation, the leaflets of such prosthetic valves open
when the upstream fluid pressure exceeds the downstream fluid
pressure on the valve and close when the downstream fluid pressure
exceeds the upstream fluid pressure on the valve. Generally, the
free edges of the leaflets coapt under the influence of downstream
fluid pressure closing the prosthetic valve to prevent downstream
blood from flowing retrograde through the prosthetic heart
valve.
[0004] Various situations arise in which the requisite diametric
profile of a prosthetic valve changes from one point in time to
another. For example, in pediatric applications, a valve of a
first, smaller inner diameter (i.e., the inner flow diameter) may
be appropriate, but following growth of the patient, a larger inner
diameter for the prosthetic valve is desirable. The removal of an
existing valve and/or implantation of another valve with a larger
flow diameter may give rise to various complications and
concomitant risks.
SUMMARY
[0005] Described embodiments are directed to apparatuses, systems,
and methods for valved conduits.
[0006] According to one example ("Example 1"), a prosthetic valve
includes one or more primary leaflets, and one or more auxiliary
leaflets stored in an inactive state, the one or more auxiliary
leaflets being configured to release to an active state upon
diametrically expanding the prosthetic valve.
[0007] According to another example ("Example 2"), further to
Example 1, the one or more auxiliary leaflets are stored in the
inactive state by one or more folds formed by the one or more
primary leaflets, the one or more folds of the primary leaflets
being releasably secured in a folded configuration and configured
to be released from the folded configuration upon diametrically
expanding the prosthetic valve to transition the auxiliary leaflets
to the active state.
[0008] According to another example ("Example 3"), further to
Example 2, at least one of the primary leaflets includes a first
side region, a second side region, and a central region located
between the first and second side regions, and wherein the one or
more folds are formed in at least one of the first side region, the
second side region, and the central region.
[0009] According to another Example ("Example 4"), further to
Example 3 or Example 4, the one or more folds formed by the one or
more primary leaflets are releasably secured in the folded
configuration by a coating, an adhesive, a thermal bond, a
mechanical fastener, or combinations thereof.
[0010] According to another Example ("Example 5"), further to any
one of Examples 2-4, the one or more folds formed by the one or
more primary leaflets are releasably secured in the folded
configuration such that the folds formed by the primary leaflets
are configured to be released from the folded configuration upon an
expansion force being imparted on the prosthetic valve and/or
following an extended period of time.
[0011] According to another Example ("Example 6"), further to any
one of Examples 2-5, the one or more primary leaflets include a
pair of adjacent primary leaflets and the one or more folds formed
by the primary leaflets are positioned at a location corresponding
to a commissure region between pair of adjacent primary
leaflets.
[0012] According to another Example ("Example 7"), further to any
one of Examples 1-6, the prosthetic valve includes a support
structure to which the one or more primary leaflets are
coupled.
[0013] According to another Example ("Example 8"), further to
Example 7, the support structure includes a tubular conduit.
[0014] According to another Example ("Example 9"), further to
Example 7 or Example 8, wherein the support structure includes a
frame.
[0015] According to another Example ("Example 10"), further to any
one of Examples 7-9, the one or more auxiliary leaflets are stored
in the inactive state by one or more folds formed by the support
structure, the folds of the support structure each being releasably
secured in a folded configuration and configured to be released
from the folded configuration upon diametrically expanding the
prosthetic valve to transition the auxiliary leaflets to the active
state.
[0016] According to another Example ("Example 11"), further to
Example 10, the one or more folds formed by the support structure
are releasably secured in the folded configuration by a coating, an
adhesive, a thermal bond, a mechanical fastener, or combinations
thereof.
[0017] According to another Example ("Example 12"), further to
Examples 10 or 11, the one or more folds formed by the support
structure are releasably secured in the folded configuration such
that the folds formed by the support structure are configured to
release from the folded configuration upon an expansion force being
imparted on the prosthetic valve and/or following an extended
period of time.
[0018] According to another Example ("Example 13"), further to any
one of Examples 10 or 11, the one or more primary leaflets include
a pair of adjacent primary leaflets and the one or more folds
formed by the support structure are positioned at a location along
the support portion corresponding to a commissure region between
the pair of adjacent primary leaflets.
[0019] According to another Example ("Example 14"), the prosthetic
valve of any preceding Example, the primary leaflets include a pair
of adjacent, primary leaflets coupled to a splittable commissure
support, and further wherein one of the auxiliary leaflets is
coupled to the splittable commissure support such that the
auxiliary leaflet is transitionable from the stored, inactive state
to the released, active state upon diametrically expanding the
prosthetic valve to split the splittable commissure support.
[0020] According to another Example ("Example 15"), further to
Example 14, the splittable commissure support is releasably secured
together by a coating, an adhesive, a thermal bond, a mechanical
fastener, or combinations thereof.
[0021] According to another Example ("Example 16"), further to any
one of Examples 14-15, the releasable commissure support is
configured to be released and split upon an expansion force being
imparted on the prosthetic valve and/or following an extended
period of time.
[0022] According to another Example ("Example 17"), further to any
preceding Examples, the prosthetic valve has a first operative
diameter at which the prosthetic valve is configured to be
implanted and a second operative diameter that is larger than the
first operative diameter to which the prosthetic valve is
configured to be diametrically adjusted, and further wherein the
one or more of primary leaflets are operable to move between open
and closed positions to allow and inhibit flow, respectively,
through the prosthetic valve such that the primary leaflets are
configured in an active state, and further wherein the prosthetic
valve is configured such that upon transitioning to the second
operative diameter the one or more auxiliary leaflets are
transitioned to the active state such that the auxiliary leaflets
are operable to move between open and closed positions to allow and
inhibit flow, respectively, through the prosthetic valve.
[0023] According to another Example ("Example 18"), further to
Example 17, the one or more primary leaflets are configured to be
in the active state when the prosthetic valve is at the second
operative diameter.
[0024] According to another Example ("Example 19"), a method of
making a prosthetic valve includes forming a valve structure
including one or more primary leaflets and one or more auxiliary
leaflets, associating the valve structure with a support structure,
and storing the one or more auxiliary leaflets in an inactive state
such that the one or more auxiliary leaflets are configured to
release to an active state upon diametrically expanding the
prosthetic valve.
[0025] According to another Example ("Example 20"), further to the
method of Example 19, the prosthetic valve is configured to be
transitioned from a first operative diameter at which the
prosthetic valve is configured to be implanted to a second
operative diameter that is larger than the first operative
diameter, and further wherein the one or more primary leaflets are
operable to move between open and closed positions to allow and
inhibit flow, respectively, through the prosthetic valve such that
the primary leaflets are configured in an active state when the
prosthetic valve is at the first operative diameter, and further
wherein the prosthetic valve is configured such that upon
transitioning to the second operative diameter the one or more
auxiliary leaflets are transitioned from the inactive state to the
active state such that the one or more auxiliary leaflets are
operable to move between open and closed positions to allow and
inhibit flow, respectively, through the prosthetic valve.
[0026] According to another Example ("Example 21"), further to the
method of Examples 19 or 20, storing the one or more auxiliary
leaflets in the inactive state includes storing the one or more
auxiliary leaflets in one or more folds formed by the one or more
primary leaflets, a support structure of the prosthetic valve, or
both.
[0027] According to another Example ("Example 22") further to the
method of Example 21, storing the one or more auxiliary leaflets in
the inactive state further includes releasably securing the one or
more folds in a folded configuration using a coating, an adhesive,
a thermal bond, a mechanical fastener, or combinations thereof.
[0028] According to another Example ("Example 23"), a method of
diametrically adjusting a prosthetic valve includes transitioning a
prosthetic valve from a first operative diameter at which the
prosthetic valve is configured to be implanted to a second
operative diameter that is larger than the first operative
diameter, the first operative diameter including one or more
primary leaflets of the prosthetic valve being operable to move
between open and closed positions to allow and inhibit flow,
respectively, through the prosthetic valve such that the primary
leaflets are configured in an active state when the prosthetic
valve is at the first operative diameter, the first operative
diameter further including one or more auxiliary leaflets of the
prosthetic valve being stored in an inactive state in which the
auxiliary leaflets are inoperable to inhibit flow through the
valve, and the second operative diameter including the one or more
auxiliary leaflets being transitioned from the inactive state to an
active state in which the one or more auxiliary leaflets are
operable to move between open and closed positions to allow and
inhibit flow, respectively, through the prosthetic valve.
[0029] According to another Example ("Example 24"), further to the
method of Example 23, at the first operative diameter the one or
more auxiliary leaflets are stored in the inactive state by one or
more folds formed by the one or more primary leaflets, the one or
more folds of the primary leaflets being releasably secured in a
folded configuration and configured to be released from the folded
configuration upon diametrically expanding the prosthetic valve to
transition the one or more auxiliary leaflets to the active state,
and further wherein transitioning a prosthetic valve from a first
operative diameter to a second operative diameter includes
releasing the one or more folds of the primary leaflets.
[0030] According to another Example ("Example 25"), further to the
method of Example 24, at least one of the one or more primary
leaflets includes a first side region, a second side region, and a
central region located between the first and second side regions,
and wherein at the first operative diameter the one or more folds
of the primary leaflets are formed in at least one of the first
side region, the second side region, and the central region.
[0031] According to another Example ("Example 26"), further to the
method of Example 24, the one or more folds formed by the one or
more leaflets are releasably secured in the folded configuration by
a coating, an adhesive, a thermal bond, a mechanical fastener, or
combinations thereof.
[0032] According to another Example ("Example 27"), further to the
method of Example 24, the one or more folds formed by the one or
more primary leaflets are released from the folded configuration by
imparting an expansion force on the prosthetic valve and/or
following an extended period of time in a body of a patient.
[0033] According to another Example ("Example 28"), further to the
method of Example 24, the one or more primary leaflets include a
pair of adjacent, primary leaflets coupled to a splittable
commissure support, and further wherein one of the auxiliary
leaflets is coupled to the splittable commissure support, the
method further comprising transitioning the auxiliary leaflet
coupled to the commissure support from the stored, inactive state
to the released, active state by splitting the splittable
commissure support.
[0034] According to another Example ("Example 29"), a prosthetic
valve includes one or more leaflets, the leaflets define a
contained portion and an uncontained portion that is exposed to a
fluid flow through the valve when the valve defines a first
diameter at which the prosthetic valve is configured to be
implanted, and wherein the contained portion becomes uncontained
and exposed to a fluid flow through the valve when the valve
defines a second diameter that is larger than the first
diameter.
[0035] According to another Example ("Example 30"), further to the
prosthetic valve of Example 29, further includes a support
structure defining an upstream end and a downstream end, the valve
structure being arranged within the support structure such that the
valve structure is configured to allow flow in upstream end out of
the downstream end while inhibiting flow from the downstream end
out the upstream end.
[0036] According to another Example ("Example 31"), further to the
prosthetic valve of Example 30, the support structure includes a
compression layer in which the contained portion is stored, the
compression layer being configured to be collapsed upon expansion
of the prosthetic valve from the first diameter to the second
diameter such that the contained portion is exposed from the
compression layer.
[0037] According to another Example ("Example 32"), further to
Example the prosthetic valve of Example 31, the support structure
includes an inner layer, an outer layer, and the compression layer
is located between the inner layer and the outer layer to define a
compressible space, the inner layer being configured to expand
outwardly against the compression layer under a radial expansion
force while the outer layer resists outward deformation such that
the compression layer is radially collapsed.
[0038] According to another Example ("Example 33"), further to
Examples 31 or 32, the compression layer includes one or more
biasing elements.
[0039] According to another Example ("Example 34"), further to any
one of Example 31 to 33, the compression layer includes a
compressible material.
[0040] According to another Example ("Example 35"), further to
Example 30, the contained portion is releasably secured to the
support structure at the first diameter and is configured to be
released from the support structure when the valve structure is
transitioned to the second diameter.
[0041] According to another Example ("Example 36"), further to
Example 29, the contained portion is releasably secured to the
exposed portion at the first diameter and is configured to be
released when the valve structure is transitioned to the second
diameter.
[0042] According to another Example ("Example 37"), a method of
making a prosthetic valve includes forming a valve structure
including one or more leaflets, and arranging the valve structure
within a support structure, the valve structure being arranged
within the support structure such that the valve structure is
configured to allow flow in upstream end out of the downstream end
while inhibiting flow from the downstream end out the upstream end,
wherein the leaflets define a contained portion and an uncontained
portion that is exposed to a fluid flow through the valve when the
valve defines a first diameter at which the prosthetic valve is
configured to be implanted, and wherein the contained portion is
configured to become uncontained and exposed to a fluid flow
through the valve when the valve is transitioned to a second
diameter that is larger than the first diameter.
[0043] According to another Example ("Example 38"), further to the
method of Example 37, the method also includes storing the
contained portion within a compression layer of the support
structure, the compression layer being configured to be collapsed
upon expansion of the prosthetic valve from the first diameter to
the second diameter such that the contained portion is exposed from
the compression layer.
[0044] According to another Example ("Example 39"), further to the
method of Example 38, the method also includes providing the
support structure with an inner layer and an outer layer such that
the compression layer is located between the inner layer and the
outer layer to define a compressible space, the inner layer being
configured to expand outwardly against the compression layer under
a radial expansion force while the outer layer resists outward
deformation such that the compression layer is radially
collapsed.
[0045] According to another Example ("Example 40"), further to the
method of Example 39, the compression layer includes one or more
biasing elements that maintain spacing between the inner layer and
the outer layer.
[0046] According to another Example ("Example 41"), further to the
method of any one of Examples 38-40, the compression layer includes
a compressible material.
[0047] According to another Example ("Example 42"), further to the
method of any one of Example 38, the method also includes
releasably securing the contained portion to the support structure
at the first diameter such that the contained portion is configured
to be released from the support structure when the valve structure
is transitioned to the second diameter.
[0048] According to another Example ("Example 43"), a prosthetic
valve includes a support structure, and a valve structure coupled
to the support structure, the valve structure including, one or
more primary leaflets, and one or more secondary leaflets adjacent
to the primary leaflets, wherein the primary leaflets function to
inhibit flow in a first direction and allow flow in a second
direction through the prosthetic valve and the secondary leaflets
are not functional to inhibit flow in the first direction and allow
flow in the second direction through the prosthetic valve when the
prosthetic valve is at a first diameter at which the prosthetic
valve is configured to be implanted, wherein the prosthetic valve
is configured to be transitioned to a second diameter that is
larger than the first diameter, and wherein the prosthetic valve is
configured such that the primary leaflets and the secondary
leaflets function to inhibit flow in the first direction and allow
flow in the second direction through the prosthetic valve after the
prosthetic valve is transitioned to the second state.
[0049] According to another Example ("Example 44"), a prosthetic
valve includes a support structure, and a valve structure coupled
to the support structure, the valve structure including, one or
more leaflets including a central region and two side regions on
opposite sides of the central region, wherein the central region is
configured to be active and the two side regions are configured to
be inactive when the prosthetic valve is at a first diameter at
which the prosthetic valve is configured to be implanted such that
the valve structure operates to inhibit flow in a first direction
and allow flow in a second direction through the prosthetic valve
at the first diameter and further wherein the central region and
the two side regions are configured to be active when the
prosthetic valve is at a second diameter that is larger than the
first diameter such that the valve structure operates to inhibit
flow in the first direction and allow flow in the second direction
through the prosthetic valve at the second diameter.
[0050] According to another Example ("Example 45"), further to the
prosthetic valve of Example 44, the two side regions are releasably
folded such that the two side regions are inactive.
[0051] According to another Example ("Example 46"), further to the
prosthetic valve of Examples 44 or 45, the support structure
comprises a conduit having an inner surface, and further wherein
the two side regions are releasably coupled to the inner surface of
the conduit such that the two side regions are inactive and the two
side regions are releasable from the conduit when the prosthetic
valve is expanded to the second diameter.
[0052] According to another Example ("Example 47"), a method of
making a prosthetic valve includes coupling a valve structure to a
support structure, the valve structure including, one or more
leaflets including a central region and two side regions on
opposite sides of the central region, wherein the central region is
configured to be active and the two side regions are configured to
be inactive when the prosthetic valve is at a first diameter at
which the prosthetic valve is configured to be implanted such that
the valve structure operates to inhibit flow in a first direction
and allow flow in a second direction through the prosthetic valve
at the first diameter and further wherein the central region and
the two side regions are configured to be active when the
prosthetic valve is at a second diameter that is larger than the
first diameter such that the valve structure operates to inhibit
flow in the first direction and allow flow in the second direction
through the prosthetic valve at the second diameter.
[0053] According to another Example ("Example 48"), further to the
method of Example 47, the method includes the two side regions are
folded in the inactive state.
[0054] According to another Example ("Example 49"), further to the
method of Example 47, the method includes the support structure
comprises a conduit having an inner surface, the method further
comprising folding the two side regions and coupling the two side
regions to the inner surface of the conduit such that the two side
regions are releasable from the conduit when the prosthetic valve
is expanded to the second diameter.
[0055] According to another Example ("Example 50"), a prosthetic
valve includes a support structure, and a valve structure coupled
to the support structure, the valve structure including, one or
more leaflets including a central region and two side regions on
opposite sides of the central region, wherein the central region is
releasably folded to define an overlapping region such that the
valve structure operates to inhibit flow in a first direction and
allow flow in a second direction through the prosthetic valve at a
first diameter at which the prosthetic valve is configured to be
implanted and wherein the overlapping region is releasable such
that the central portion is unfolded and the valve structure
operates to inhibit flow in the first direction and allow flow in
the second direction through the prosthetic valve at a second
diameter that is larger than the first diameter.
[0056] According to another Example ("Example"), a method of making
a prosthetic valve includes coupling a support structure to a valve
structure, the valve structure including one or more leaflets
including a central region and two side regions on opposite sides
of the central region, wherein the central region is releasably
folded to define an overlapping region such that the valve
structure operates to inhibit flow in a first direction and allow
flow in a second direction through the prosthetic valve at a first
diameter at which the prosthetic valve is configured to be
implanted and wherein the overlapping region is releasable such
that the central portion is unfolded and the valve structure
operates to inhibit flow in the first direction and allow flow in
the second direction through the prosthetic valve at a second
diameter that is larger than the first diameter.
[0057] According to another Example ("Example"), a prosthetic valve
includes a support structure, and a valve structure coupled to the
support structure, the valve structure including, one or more
leaflets including a central region and two side regions on
opposite sides of the central region, wherein the side regions are
releasably folded defining an overlapping region such that the
valve structure operates to inhibit flow in a first direction and
allow flow in a second direction through the prosthetic valve at a
first diameter at which the prosthetic valve is configured to be
implanted and wherein the overlapping region is releasable such
that the side regions are unfolded and the valve structure operates
to inhibit flow in the first direction and allow flow in the second
direction through the prosthetic valve at a second diameter that is
larger than the first diameter.
[0058] According to another Example ("Example 53"), a method of
making a prosthetic valve, the method includes coupling a support
structure to a valve structure, the valve structure including one
or more leaflets including a central region and two side regions on
opposite sides of the central region, wherein the side regions are
releasably folded defining an overlapping region such that the
valve structure operates to inhibit flow in a first direction and
allow flow in a second direction through the prosthetic valve at a
first diameter at which the prosthetic valve is configured to be
implanted and wherein the overlapping region is releasable such
that the side regions are unfolded and the valve structure operates
to inhibit flow in the first direction and allow flow in the second
direction through the prosthetic valve at a second diameter that is
larger than the first diameter.
[0059] According to another Example ("Example 54"), a prosthetic
valve a first leaflet component, and a second leaflet component at
least partially overlapping the first leaflet component to define
an overlap region having a width, the first leaflet component and
the second leaflet component configured to be in operable
engagement with one another when the prosthetic valve is at a first
diameter at which the prosthetic valve is configured to be
implanted to allow fluid flow through the prosthetic valve in a
first direction and inhibit fluid flow through the prosthetic valve
in an opposite, second direction, and the first leaflet component
and the second leaflet component being configured to be in operable
engagement with one another when the prosthetic valve is at a
second diameter that is larger than the first diameter by sliding
relative to each other thereby reducing the width of the overlap
region as the diameter of the prosthetic valve is increased, such
that the first and second leaflet components allow fluid flow
through the prosthetic valve in the first direction and inhibit
fluid flow through the prosthetic valve in the opposite, second
direction when the prosthetic valve is at the second, larger
diameter.
[0060] According to another Example ("Example 55"), further to the
prosthetic valve of Example 54, the prosthetic valve includes the
first leaflet component includes a cut out at a side region of the
first leaflet component to assist with diametric expansion of the
first leaflet component.
[0061] According to another Example ("Example 56"), further to the
prosthetic valve of Example 55, the prosthetic valve includes the
second leaflet component overlaps cut out in the side region of the
first leaflet component.
[0062] According to another Example ("Example 57"), further to the
prosthetic valve of any one of Examples 54-56, the prosthetic valve
includes the second leaflet component is located downstream of the
first leaflet component.
[0063] According to another Example ("Example 58"), further to the
prosthetic valve of any one of Examples 54-57, the prosthetic valve
further includes another second leaflet component that is disposed
downstream of and at least partially overlapping with the first
leaflet component.
[0064] According to another Example ("Example 59"), further to the
prosthetic valve of any one of Examples 54-58, the prosthetic valve
further includes a support structure, wherein the first leaflet
component and the second leaflet component are coupled to the
support structure.
[0065] According to another Example ("Example 60"), a method of
making a prosthetic valve, the method includes coupling a support
structure to a valve structure, the valve structure including, a
first leaflet component, and a second leaflet component at least
partially overlapping the first leaflet component to define an
overlap region having a width, the first leaflet component and the
second leaflet component configured to be in operable engagement
with one another when the prosthetic valve is at a first diameter
at which the prosthetic valve is configured to be implanted to
allow fluid flow through the prosthetic valve in a first direction
and inhibit fluid flow through the prosthetic valve in an opposite,
second direction, and the first leaflet component and the second
leaflet component being configured to be in operable engagement
with one another when the prosthetic valve is at a second diameter
that is larger than the first diameter by sliding relative to each
other thereby reducing the width of the overlap region as the
diameter of the prosthetic valve is increased, such that the first
and second leaflet components allow fluid flow through the
prosthetic valve in the first direction and inhibit fluid flow
through the prosthetic valve in the opposite, second direction when
the prosthetic valve is at the second, larger diameter.
[0066] According to another Example ("Example 61"), a prosthetic
valve includes a diametrically adjustable frame comprising a
plurality of frame elements slidably engaged with one another, and
a plurality of leaflets coupled to the diametrically adjustable
frame, each of the leaflets being secured to a respective one of
the frame elements such that stored leaflet material is stored in
an inactive state when the adjustable frame is at a first diameter
at which the prosthetic valve is configured to be implanted, each
of the leaflets defining a first active size at the first diameter
such that the leaflets allow fluid flow through the prosthetic
valve in a first direction and inhibit fluid flow through the
prosthetic valve in an opposite, second direction, the adjustable
frame being transitionable to a second diameter that is larger than
the first diameter by sliding the plurality of frame elements
relative to one another to diametrically enlarge the diametrically
adjustable frame and such that the stored leaflet material is paid
out to enlarge the active size of the each of the leaflets to a
second active size as the adjustable frame is diametrically
enlarged to the second diameter, and such that each of the leaflets
allow fluid flow through the prosthetic valve in the first
direction and inhibit fluid flow through the prosthetic valve in
the opposite, second direction at the second active size.
[0067] According to another Example ("Example 62"), further to the
prosthetic valve of Example 61, each of the plurality of frame
elements include tabs for slidably engaging another one of the
plurality of frame elements.
[0068] According to another Example ("Example 63"), further to the
prosthetic valve of Examples 61-62, each of the frame elements
includes a top rail, a bottom rail, a leaflet payout edge support,
a primary leaflet edge support and a secondary leaflet edge
support.
[0069] According to another Example ("Example 64"), further to the
prosthetic valve of Example 63, each leaflet is secured to a
corresponding one of the plurality frame elements, where each
leaflet is secured to the leaflet payout edge support and the
primary leaflet edge support of the corresponding one of the
plurality of frame elements such that the primary leaflet edge
support of the corresponding one of the plurality of frame elements
serves to define a first operative edge of the leaflet and the
secondary leaflet edge support of another one of the plurality of
frame elements serves to define a second operative edge of the
leaflet that is opposite the first operative edge of the
leaflet.
[0070] According to another Example ("Example 65"), further to the
prosthetic valve of any one of Examples 61-64, the frame elements
are axi-symmetric.
[0071] According to another Example ("Example 66"), further to the
prosthetic valve of any one of Examples 61-65, the diametrically
adjustable frame includes retaining features configured act as
stops that limit relative sliding of the plurality of frame
elements at one or more pre-selected diameters of the adjustable
frame.
[0072] According to another Example ("Example 67"), a method of
making a prosthetic valve, the method includes securing a plurality
of adjustable frame elements of an adjustable frame together such
that the plurality of adjustable frame elements are slidable
relative to one another to adjust a diameter of the adjustable
frame from a first diameter at which the prosthetic valve is
configured to be implanted to a second diameter that is larger than
the first diameter, and coupling a plurality of leaflets to the
diametrically adjustable frame with each of the leaflets being
secured to a corresponding one of the frame elements such that
stored leaflet material is stored in an inactive state when the
adjustable frame is at a first diameter and each of the leaflets
defines a first active size at the first diameter such that the
leaflets allow fluid flow through the prosthetic valve in a first
direction and inhibit fluid flow through the prosthetic valve in an
opposite, second direction and such that upon transitioning the
adjustable frame to the second diameter by sliding the plurality of
frame elements relative to one another the stored leaflet material
is paid out to enlarge the active size of the each of the leaflets
to a second active size at which each of the leaflets allow fluid
flow through the prosthetic valve in the first direction and
inhibit fluid flow through the prosthetic valve in the opposite,
second direction.
[0073] According to another Example ("Example 68"), further to the
method of Example 67, each of the plurality of frame elements
include tabs, and further wherein securing a plurality of
adjustable frame elements of an adjustable frame together further
includes slidably coupling the adjustable frame elements together
with the tabs.
[0074] According to another Example ("Example 69"), further to the
method of Example 67 or Example 68, each of the frame elements
includes a top rail, a bottom rail, a leaflet payout edge support,
a primary leaflet edge support and a secondary leaflet edge
support, wherein coupling a plurality of leaflets to the
diametrically adjustable frame with each of the leaflets being
secured to a corresponding one of the frame elements includes
securing each leaflet to the corresponding one of the plurality
frame elements such that each leaflet is secured to the leaflet
payout edge support and the primary leaflet edge support of the
corresponding one of the plurality of frame elements with the
primary leaflet edge support of the corresponding one of the
plurality of frame elements serving to define a first operative
edge of the leaflet and the secondary leaflet edge support of
another one of the plurality of frame elements serves to define a
second operative edge of the leaflet that is opposite the first
operative edge of the leaflet.
[0075] According to another Example ("Example 70"), further to the
method of any one of Examples 67-69, the diametrically adjustable
frame includes retaining features, the method further comprising
engaging the retaining features of the diametrically adjustable
frame to act as stops that limit relative sliding of the plurality
of frame elements at one or more pre-selected diameters of the
adjustable frame.
[0076] According to another Example ("Example 71"), a prosthetic
valve includes a first diametrically adjustable frame element
configured to support a valve structure, and a second diametrically
adjustable frame element coupled to the first diametrically
adjustable frame element, the second diametrically adjustable frame
element including a selective expansion feature for reinforcement
of the first diametrically adjustable frame element against
compression at a first diameter at which the prosthetic valve is
configured to be implanted and reinforcement of the first
diametrically adjustable frame element against compression
following diametric expansion of the first frame element to a
second diameter that is larger than the first diameter.
[0077] According to another Example ("Example 72"), further to the
prosthetic valve of Example 71, the selective expansion feature is
configured to self-engage upon compression at the first
diameter.
[0078] According to another Example ("Example 73"), further to the
prosthetic valve of Example 71 or Example 72, the selective
expansion feature has an undulating shape at the first diameter and
more straight, less undulating shape at the second diameter.
[0079] According to another Example ("Example 74"), a method of
making a prosthetic valve, the method includes coupling a first
diametrically adjustable frame element to a second diametrically
adjustable frame element, the first diametrically frame element
being configured to support a valve structure and the second
diametrically adjustable frame element including a selective
expansion feature for reinforcement of the first diametrically
adjustable frame element against compression at a first diameter at
which the prosthetic valve is configured to be implanted and
reinforcement of the first diametrically adjustable frame element
against compression following diametric expansion of the first
frame element to a second diameter.
[0080] According to another Example ("Example 75"), further to the
method of Example 74, the selective expansion feature is configured
to self-engage upon compression at the first diameter.
[0081] According to another Example ("Example 76"), further to the
method of Example 74 or Example 75, the selective expansion feature
has an undulating shape at the first diameter and more straight,
less undulating shape at the second diameter.
[0082] According to another Example ("Example 77"), a prosthetic
valve includes a smaller, first prosthetic valve having a first
inner diameter and including a first support structure and a first
valve structure in an active state such that the first valve
structure is configured to allow fluid flow through the prosthetic
valve in a first direction and inhibit fluid flow through the
prosthetic valve in an opposite, second direction, and a larger,
second prosthetic valve having a second inner diameter that is
larger than the first inner diameter of the smaller, first
prosthetic valve and including a second support structure and a
second valve structure in an inactive state such that the second
valve structure is inoperable to inhibit fluid flow through the
prosthetic valve, wherein the smaller, first prosthetic valve is
releasably secured within the larger, second prosthetic valve such
that the smaller, first prosthetic valve is configured to be
released and removed from the larger, second prosthetic valve to
transition the second valve structure to an active state in which
the second valve structure is configured to allow fluid flow
through the prosthetic valve in the first direction and inhibit
fluid flow through the prosthetic valve in the opposite, second
direction.
[0083] According to another Example ("Example 78") The prosthetic
valve of Example 77, the smaller, first prosthetic valve is
releasably secured within the larger, second prosthetic valve such
that the smaller, first prosthetic valve is configured to be
everted and peeled from within the larger, second prosthetic
valve.
[0084] According to another Example ("Example 79"), further to the
prosthetic valve of Example 77 or Example 78, the larger, second
prosthetic valve includes a support layer and an intermediate layer
disposed inside of the support layer, the intermediate layer being
releasably coupled to the first support structure of the smaller,
first prosthetic valve.
[0085] According to another Example ("Example 80"), further to the
prosthetic valve of Example 79, the intermediate layer is
configured to retain stored portions of the second valve structure
such that the second valve structure is configured to initially
operate at an initial inner diameter that approximates the first
inner diameter of the smaller, first valve.
[0086] According to another Example ("Example 81"), further to the
prosthetic valve of Example 80, the intermediate layer is
compressible and/or removable over time to increase the initial
inner diameter at which the second valve structure operates to the
second inner diameter by releasing the stored portions of the
second valve structure.
[0087] According to another Example ("Example 82"), a method of
making a prosthetic valve, the method includes securing a smaller,
first prosthetic valve within a larger, second prosthetic valve,
the smaller, first prosthetic valve having a first inner diameter
and including a first support structure and a first valve structure
in an active state such that the first valve structure is
configured to allow fluid flow through the prosthetic valve in a
first direction and inhibit fluid flow through the prosthetic valve
in an opposite, second direction and the larger, second prosthetic
valve having a second inner diameter that is larger than the first
inner diameter of the smaller, first prosthetic valve and including
a second support structure and a second valve structure, the second
valve structure being in an inactive state such that the second
valve structure is inoperable to inhibit fluid flow through the
prosthetic valve, wherein the smaller, first prosthetic valve is
secured within the larger, second prosthetic valve such that the
smaller, first prosthetic valve is releasable and removable from
the larger, second prosthetic valve to transition a second valve
structure from an inactive state to an active state in which the
second valve structure is configured to allow fluid flow through
the prosthetic valve in the first direction and inhibit fluid flow
through the prosthetic valve in the opposite, second direction.
[0088] According to another Example ("Example 83"), further to the
method of making the prosthetic valve of Example 82, the smaller,
first prosthetic valve is releasably secured within the larger,
second prosthetic valve such that the smaller, first prosthetic
valve is configured to be everted and peeled from within the
larger, second prosthetic valve.
[0089] According to another Example ("Example 84"), further to the
method of making the prosthetic valve of Example 82 or Example 83,
the larger, second prosthetic valve includes a support layer and an
intermediate layer disposed inside of the support layer, the method
further comprising releasably coupling the intermediate to the
first support structure of the smaller, first prosthetic valve.
[0090] According to another Example ("Example 85"), further to the
method of making the prosthetic valve of Example 84, the
intermediate layer retains stored portions of the second valve
structure such that the second valve structure is configured to
initially operate at an initial inner diameter that approximates
the first inner diameter of the smaller, first valve.
[0091] According to another Example ("Example 86"), further to the
method of making the prosthetic valve of Example 85, the
intermediate layer is compressible and/or removable over time to
increase the initial inner diameter at which the second valve
structure operates to the second inner diameter by releasing the
stored portions of the second valve structure.
[0092] According to another Example ("Example 87"), a method of
forming a prosthetic valve that is diametrically adjustable, the
method comprising manufacturing a prosthetic valve at an initial,
maximum diameter with a valve structure of the prosthetic valve
configured to coapt, and then diametrically compacting the
prosthetic valve to a smaller inner diameter at which the
prosthetic valve is configured to be implanted such that the inner
diameter of the prosthetic valve is decreased and portions of a
valve structure of the prosthetic valve are reversibly attached to
an inner surface of the prosthetic valve, where portions of the
valve structure that are unattached to the inner surface of the
prosthetic valve are configured to operatively coapt at the smaller
diameter at which the prosthetic valve is configured to be
implanted.
[0093] According to another Example ("Example 88"), a prosthetic
valve includes a support structure having an inflow end and an
outflow end, the support structure configured to be diametrically
adjusted from a first diameter at which the prosthetic valve is
configured to be implanted to a second diameter that is larger than
the first diameter, the support structure including a support
portion defining a base, a first leg, a second leg, a first
commissure support, and a second commissure support, and a valve
structure arranged within the support structure and coupled to the
support portion of the support structure, the valve structure being
configured to allow flow in a first direction through the
prosthetic valve while inhibiting flow through the prosthetic valve
in a second direction that is opposite the first direction when the
support structure is at the first diameter and when the support
structure is at the second diameter, the valve structure including
one or more leaflets each having an attachment zone corresponding
to a portion of the leaflet that is coupled to the support portion
of the support structure, each leaflet defining a base, a free
edge, a first commissure region, a second commissure region, and a
belly region, and each leaflet being configured such that the free
edge coapts at both the first diameter and the second diameter of
the support structure.
[0094] According to another Example ("Example 89"), further to the
prosthetic valve of Example 88, each leaflet is configured with
sufficient material in the belly region to accommodate a reduction
in overall height of the valve structure as the diameter of support
structure increases.
[0095] According to another Example ("Example 90"), further to the
prosthetic valve of Example 88 or Example 89, the support structure
further includes a conduit portion, and further wherein the support
portion is more resistant to diametric adjustment than the conduit
portion, such that during diametric adjustment of the support
structure deformation of the support structure occurs
preferentially at the conduit portion.
[0096] According to another Example ("Example 91"), further to the
prosthetic valve of any one of Examples 88-90, the support portion
includes one or more resistant regions and one or more deformation
regions that have relatively decreased resistance to the
deformation regions such that preferential expansion during
diametric adjustment of the support structure occurs preferentially
in the one or more deformation regions of the support portion.
[0097] According to another Example ("Example 92"), further to the
prosthetic valve of Example 91, the one or more resistant regions
are more resistant to creep than the one or more deformation
regions.
[0098] According to another Example ("Example 93"), further to the
prosthetic valve of Example 91 or Example 92, the one or more
resistant regions includes a coating, a surface treatment, a
reinforcement element, or combinations thereof for enhancing
resistance to deformation relative to the one or more deformation
regions.
[0099] According to another Example ("Example 94"), a method of
making a prosthetic valve, the method includes arranging a valve
structure within a support structure, the support structure having
an inflow end and an outflow end and being configured to be
diametrically adjusted from a first diameter at which the
prosthetic valve is configured to be implanted to a second diameter
that is larger than the first diameter, the support structure
including a support portion defining a base, a first leg, a second
leg, a first commissure support, and a second commissure support,
and coupling the valve structure to the support portion of the
support structure, such that the valve structure is configured to
allow flow in a first direction through the prosthetic valve while
inhibiting flow through the prosthetic valve in a second direction
that is opposite the first direction when the support structure is
at the first diameter and when the support structure is at the
second diameter, the valve structure including one or more leaflets
each having an attachment zone corresponding to a portion of the
leaflet that is coupled to the support portion of the support
structure, each leaflet defining a base, a free edge, a first
commissure region, a second commissure region, and a belly region,
and each leaflet being configured such that the free edge coapts at
both the first diameter and the second diameter of the support
structure.
[0100] According to another Example ("Example 95"), further to the
method of Example 94, each leaflet is coupled to the support
structure such that each leaflet is configured with sufficient
material in the belly region to accommodate a reduction in overall
height of the valve structure as the diameter of support structure
increases.
[0101] According to another Example ("Example 96"), further to the
method of Example 94 or Example 95, the support structure further
includes a conduit portion, and further wherein the support portion
is more resistant to diametric adjustment than the conduit portion,
such that during diametric adjustment of the support structure
deformation of the support structure occurs preferentially at the
conduit portion.
[0102] According to another Example ("Example 97"), further to the
method of any one of Example 94-96, the support portion includes
one or more resistant regions and one or more deformation regions
that have relatively decreased resistance to the deformation
regions such that preferential expansion during diametric
adjustment of the support structure occurs preferentially in the
one or more deformation regions of the support portion.
[0103] According to another Example ("Example 98"), further to the
method of Example 97, the one or more resistant regions are more
resistant to creep than the one or more deformation regions.
[0104] According to another Example ("Example 99"), further to the
method of Example 97 or Example 98, the one or more resistant
regions includes a coating, a surface treatment, a reinforcement
element, or combinations thereof for enhancing resistance to
deformation relative to the one or more deformation regions.
[0105] According to one example ("Example 100"), a prosthetic valve
includes a plurality of primary leaflets, and one or more auxiliary
leaflets stored in an inactive state, the secondary leaflets being
configured to release to an active state upon diametrically
expanding the prosthetic valve.
[0106] According to another example ("Example 101") further to
Example 100, the auxiliary leaflets are stored in the inactive
state by one or more folds in the primary leaflets and one or more
folds in a support structure of the prosthetic valve.
[0107] According to another example ("Example 102"), a prosthetic
valve includes a pair of adjacent, primary leaflets coupled to a
splittable commissure support, and an auxiliary leaflet coupled to
the splittable commissure support, wherein the auxiliary leaflet is
transitionable from a stored, inactive state to a released active
state upon diametrically expanding the prosthetic valve to split
the splittable commissure support.
[0108] According to another example ("Example 103), a prosthetic
valve includes a plurality of leaflets, wherein the leaflets define
a contained portion and an uncontained portion that is exposed to a
fluid flow through the valve when the valve defines a first
diameter, and wherein the contained portion becomes uncontained and
exposed to a fluid flow through the valve when the valve defines a
second diameter that is larger than the first diameter.
[0109] According to another example, ("Example 104"), a prosthetic
valve includes a plurality of primary leaflets, and one or more
secondary leaflets adjacent to one or more of the primary leaflets,
wherein the secondary leaflet is operable to be non-functional in a
first state wherein the valve is at a first diameter and functional
in a second state wherein the valve is at a second diameter that is
larger than the first diameter.
[0110] According to another example, ("Example 105"), a prosthetic
valve includes a plurality of leaflets, each leaflet including a
free edge and a base, wherein each leaflet includes a central
region and two side regions on opposite sides of the central
region, wherein the two side regions are operable to be inactive in
a first state wherein the valve is at a first diameter and active
in a second state wherein the valve is at a second diameter that is
larger than the first diameter.
[0111] According to another example, ("Example 106"), further to
Example 105, the two side regions are folded in the inactive
state.
[0112] According to another example, ("Example 107"), further to
Example 105, the prosthetic valve further includes a conduit,
wherein the leaflets are adjacent an inner surface of the conduit,
wherein the two side regions are folded and adhered to the conduit
wherein the valve is at a first diameter and wherein the two side
regions are released from the conduit wherein the valve is expanded
to the second diameter.
[0113] According to another example, ("Example 108"), further to
Example 105, the prosthetic valve further includes a conduit,
wherein the leaflets are adjacent an inner wall of the conduit,
wherein the two side regions are folded and adhered to the conduit
wherein the valve is at a first diameter and wherein the two side
regions are released from the conduit wherein the valve is at the
second diameter.
[0114] According to another example, ("Example 109"), a prosthetic
valve includes a plurality of leaflets, each leaflet including a
free edge and a base, wherein each leaflet includes a central
region and two side regions on opposite sides of the central
region, wherein the central region is folded defining an
overlapping region in a first state wherein the valve is at a first
diameter and wherein the folded region is not folded in a second
state wherein the valve is at a second diameter that is larger than
the first diameter.
[0115] According to another example, ("Example 110"), a prosthetic
valve includes a plurality of leaflets, each leaflet including a
free edge and a base, wherein each leaflet includes a central
region and two side regions on opposite sides of the central
region, wherein the side regions are folded defining an overlapping
region in a first state wherein the valve is at a first diameter
and wherein the folded region is not folded in a second state
wherein the valve is at a second diameter that is larger than the
first diameter.
[0116] According to another example, ("Example 111"), a prosthetic
valve, includes a first leaflet component and a second leaflet
component being disposed downstream of and at least partially
overlapping the first leaflet component defining an overlap region
defining a width, the first leaflet component and the second
leaflet component are in operable engagement configured to allow
forward fluid flow through the prosthetic valve in a first
direction extending downstream and prevent retrograde fluid flow
through the prosthetic valve in an opposite direction extending
upstream, and in operable engagement configured to allow the first
leaflet and the second leaflet to slide relative to each other
reducing the width of the overlap region as the diameter of the
valve is increased.
[0117] According to another example, ("Example 112"), a prosthetic
valve includes a diametrically adjustable frame comprising a
plurality of frame elements coupled to a plurality of leaflets,
each of the leaflets being secured to a respective one of the frame
elements such that leaflet material is stored when the prosthetic
valve is at a first diameter and each of the leaflets defines a
first active size and is paid out to enlarge the active size of the
each of the leaflets as the adjustable frame is diametrically
enlarged.
[0118] According to another example, ("Example 113"), a prosthetic
valve, includes a first diametrically adjustable frame element
configured to support a valve structure and a second diametrically
adjustable frame element coupled to the first diametrically
adjustable frame element, the second diametrically adjustable frame
element including a selective expansion feature for reinforcement
of the first diametrically adjustable frame element against
compression at a first diameter and reinforcement of the first
diametrically adjustable frame element against compression
following diametric expansion of the first frame element to a
second diameter.
[0119] According to another example, ("Example 114"), further to
Example 113, the selective expansion feature is configured to
self-engage upon compression at the first diameter.
[0120] According to another example, ("Example 115"), further to
Example 113, the selective expansion feature has an undulating
shape at the first diameter and more straight, less undulating
shape at the second diameter.
[0121] According to another example, ("Example 116"), a prosthetic
valve includes a smaller, first prosthetic valve having a smaller
inner diameter and including a first support structure and a first
valve structure in an active state, a larger, second prosthetic
valve having a larger inner diameter and including a second support
structure and a second valve structure in an inactive state, the
smaller, first prosthetic valve being releasably secured inside of
the larger, second prosthetic valve such that the smaller, first
prosthetic valve is configured to be retracted from the larger,
second prosthetic valve and to transition the second valve
structure to an active state.
[0122] According to another example, ("Example 117"), a method of
treatment includes accessing a prosthetic valve according to any of
the preceding Examples that has been implanted in a body of a
patient and diametrically adjusting the prosthetic valve from a
first inner diameter at which the prosthetic valve was implanted to
a second, larger inner diameter.
[0123] According to another example, ("Example 118"), a method of
forming a prosthetic valve that is diametrically adjustable
includes manufacturing a prosthetic valve at an initial, maximum
diameter with a valve structure of the prosthetic valve configured
to coapt, and then diametrically compacting the prosthetic valve to
a smaller inner diameter such that the inner diameter of the
prosthetic valve is decreased and portions of a valve structure of
the prosthetic valve are reversibly attached to an inner surface of
the prosthetic valve, where portions of the valve structure that
are unattached to the inner surface of the prosthetic valve are
configured to operatively coapt at the smaller diameter.
[0124] According to another example, ("Example 119"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for the body conduit, the prosthetic valve including
one or more primary leaflets and one or more auxiliary leaflets
stored in an inactive state, and securing the prosthetic valve at
the treatment site.
[0125] According to another example, ("Example 120"), further to
the method of Example 119, further comprising diametrically
adjusting the prosthetic valve implanted in a body of a patient
from a first, active diameter to a second, larger, active diameter
such that the one or more auxiliary leaflets release to an active
state.
[0126] According to another example, ("Example 121"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for the body conduit, the prosthetic valve including
one or more leaflets, wherein the leaflets define a contained
portion and an uncontained portion that is exposed to a fluid flow
through the valve when the valve defines a first diameter at which
the prosthetic valve is configured to be implanted, the contained
portion being releasable to become uncontained and exposed to a
fluid flow through the valve upon expanding the prosthetic valve to
a second diameter that is larger than the first diameter, and
securing the prosthetic valve at the treatment site.
[0127] According to another example, ("Example 122"), further to
the method of Example 121, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient from the
first diameter to the second diameter such that the contained
portion is released and exposed to a fluid flow through the
valve.
[0128] According to another example, ("Example 123"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve including a
support structure and a valve structure coupled to the support
structure, the valve structure including, one or more primary
leaflets, and one or more secondary leaflets adjacent to the
primary leaflets, wherein the primary leaflets function to inhibit
flow in a first direction and allow flow in a second direction
through the prosthetic valve and the secondary leaflets are not
functional to inhibit flow in the first direction and allow flow in
the second direction through the prosthetic valve when the
prosthetic valve is at the first, active diameter at which the
prosthetic valve is implanted, and securing the prosthetic valve at
the treatment site.
[0129] According to another example, ("Example 124"), further to
the method of Example 123, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient from the
first, active diameter to a second, larger, second active diameter
such that the primary leaflets and the secondary leaflets function
to inhibit flow in the first direction and allow flow in the second
direction through the prosthetic valve after the prosthetic valve
is transitioned to the second, larger active diameter.
[0130] According to another example, ("Example 125"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve including a
support structure a valve structure coupled to the support
structure, the valve structure including, one or more leaflets
including a central region and two side regions on opposite sides
of the central region, wherein the central region is configured to
be active and the two side regions are configured to be inactive
when the prosthetic valve is at the first diameter such that the
valve structure operates to inhibit flow in a first direction and
allow flow in a second direction through the prosthetic valve at
the first diameter, and securing the prosthetic valve at the
treatment site.
[0131] According to another example, ("Example 127"), further to
the method of Example 125, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient from the
first diameter to a second, larger diameter such that the central
region and the two side regions are active at the second diameter
and the valve structure operates to inhibit flow in the first
direction and allow flow in the second direction through the
prosthetic valve at the second, larger diameter.
[0132] According to another example, ("Example 128"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve including a
support structure a valve structure coupled to the support
structure, the valve structure including, one or more leaflets
including a central region and two side regions on opposite sides
of the central region, wherein the central region is releasably
folded to define an overlapping region such that the valve
structure operates to inhibit flow in a first direction and allow
flow in a second direction through the prosthetic valve at a first
diameter at which the prosthetic valve is implanted, and securing
the prosthetic valve at the treatment site.
[0133] According to another example, ("Example 129"), The method of
Example 128, the method also includes diametrically adjusting the
prosthetic valve implanted in the patient from the first diameter
to a second, larger diameter, the overlapping region of the central
region is released and unfolded and the valve structure operates to
inhibit flow in the first direction and allow flow in the second
direction through the prosthetic valve at the second diameter.
[0134] According to another example, ("Example 130"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve, the
prosthetic valve including a first leaflet component and a second
leaflet component at least partially overlapping the first leaflet
component to define an overlap region having a width, the first
leaflet component and the second leaflet component being in
operable engagement with one another at the first diameter at which
the prosthetic valve is implanted to allow fluid flow through the
prosthetic valve in a first direction and inhibit fluid flow
through the prosthetic valve in an opposite, second direction and
being configured to overlap to a lesser extent when the prosthetic
valve is at a second diameter that is larger than the first
diameter, and securing the prosthetic valve at the treatment
site.
[0135] According to another example, ("Example 140"), further to
the method of Example 130, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient from the
first diameter to the second diameter such the first leaflet
component and the second leaflet component remain in operable
engagement with one another at the second diameter by sliding
relative to each other thereby reducing the width of the overlap
region as the diameter of the prosthetic valve is increased, such
that the first and second leaflet components allow fluid flow
through the prosthetic valve in the first direction and inhibit
fluid flow through the prosthetic valve in the opposite, second
direction at the second, larger diameter.
[0136] According to another example, ("Example 141"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve, the
prosthetic valve including a diametrically adjustable frame
comprising a plurality of frame elements slidably engaged with one
another and a plurality of leaflets coupled to the diametrically
adjustable frame, each of the leaflets being secured to a
respective one of the frame elements such that stored leaflet
material is stored in an inactive state when the adjustable frame
is at the first diameter at which the prosthetic valve is
implanted, each of the leaflets defining a first active size at the
first diameter such that the leaflets allow fluid flow through the
prosthetic valve in a first direction and inhibit fluid flow
through the prosthetic valve in an opposite, second direction, and
securing the prosthetic valve at the treatment site.
[0137] According to another example, ("Example 142"), further to
the method of Example 141, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient from the
first diameter to a second, larger diameter such that the plurality
of frame elements slide relative to one another to diametrically
enlarge the diametrically adjustable frame such that the stored
leaflet material is paid out to enlarge the active size of the each
of the leaflets to a second active size as the adjustable frame is
diametrically enlarged to the second diameter, and such that each
of the leaflets allow fluid flow through the prosthetic valve in
the first direction and inhibit fluid flow through the prosthetic
valve in the opposite, second direction at the second active
size.
[0138] According to another example, ("Example 143"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve including a
smaller, first prosthetic valve having a first inner diameter and
including a first support structure and a first valve structure in
an active state such that the first valve structure is configured
to allow fluid flow through the prosthetic valve in a first
direction and inhibit fluid flow through the prosthetic valve in an
opposite, second direction and a larger, second prosthetic valve
having a second inner diameter that is larger than the first inner
diameter of the smaller, first prosthetic valve and including a
second support structure and a second valve structure in an
inactive state such that the second valve structure is inoperable
to inhibit fluid flow through the prosthetic valve, wherein the
smaller, first prosthetic valve is releasably secured within the
larger, second prosthetic valve, and securing the prosthetic valve
at the treatment site.
[0139] According to another example, ("Example 144"), further to
the method of Example 143, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient from a
first, active diameter to a second, larger, active diameter by
releasing and removing the smaller, first prosthetic valve from the
larger, second prosthetic valve to transition the second valve
structure to an active state in which the second valve structure
allows fluid flow through the prosthetic valve in the first
direction and inhibits fluid flow through the prosthetic valve in
the opposite, second direction.
[0140] According to another example, ("Example 145"), a method of
treatment of a body conduit of a patient susceptible to changes in
diameter over time includes delivering a prosthetic valve to a
treatment site for a body conduit, the prosthetic valve having a
first operative diameter including one or more primary leaflets of
the prosthetic valve being operable to move between open and closed
positions to allow and inhibit flow, respectively, through the
prosthetic valve such that the primary leaflets are configured in
an active state when the prosthetic valve is at the first operative
diameter, the first operative diameter further including one or
more auxiliary leaflets of the prosthetic valve being stored in an
inactive state in which the auxiliary leaflets are inoperable to
inhibit flow through the valve, and securing the prosthetic valve
at the treatment site.
[0141] According to another example, ("Example 146"), further to
the method of Example 145, the method also includes diametrically
adjusting the prosthetic valve implanted in the patient to a second
operative diameter including the one or more auxiliary leaflets
being transitioned from the inactive state to an active state in
which the one or more auxiliary leaflets are operable to move
between open and closed positions to allow and inhibit flow,
respectively, through the prosthetic valve.
[0142] The foregoing Examples are just that, and should not be read
to limit or otherwise narrow the scope of any of the inventive
concepts addressed herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0143] The accompanying drawings are included to provide a further
understanding of the disclosure and are incorporated in and
constitute a part of this specification, illustrate embodiments,
and together with the description serve to explain various
inventive concepts addressed herein.
[0144] FIG. 1 illustrates features of a diametrically adjustable
prosthetic valve, according to some embodiments.
[0145] FIG. 2 illustrates an interior downstream view of a valve
structure of the prosthetic valve of FIG. 1, according to some
embodiments.
[0146] FIG. 3 is an illustration of a leaflet that may be used in
the valve structure of FIG. 2, according to some embodiments.
[0147] FIG. 4 shows an area of the support structure of a
prosthetic valve corresponding to a valve structure of the
prosthetic valve, according to some embodiments.
[0148] FIGS. 5-7 show various support portion features, according
to some embodiments.
[0149] FIG. 8 shows a leaflet with various regions thereof outlined
in broken lines, according to some embodiments.
[0150] FIGS. 9 and 10 represent expansion features for the
prosthetic valve, according to some embodiments.
[0151] FIGS. 11-13 illustrate expansion features for the prosthetic
valve, according to some embodiments.
[0152] FIGS. 14-16 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0153] FIGS. 17-20 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0154] FIGS. 21-23 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0155] FIGS. 24-25 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0156] FIGS. 26-27 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0157] FIGS. 28-30 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0158] FIGS. 31-34 illustrate additional or alternative expansion
features for the prosthetic valve, according to some
embodiments.
[0159] FIGS. 35A and 35B illustrate additional or alternative
expansion features for the prosthetic valve, according to some
embodiments.
[0160] FIGS. 36-42 illustrate a diametrically expandable prosthetic
valve, according to some embodiments.
[0161] FIGS. 43-45 illustrate retaining features according to some
embodiments.
[0162] FIGS. 46-52 illustrate a diametrically expandable prosthetic
valve, according to some embodiments.
[0163] Persons skilled in the art will readily appreciate that
various inventive aspects described herein can be realized by any
number of methods and apparatus configured to perform the intended
functions. It should also be noted that the accompanying drawing
figures referred to herein are not necessarily drawn to scale, but
may be exaggerated to illustrate various inventive aspects, and in
that regard, the drawing figures should not be construed as
limiting.
DETAILED DESCRIPTION
[0164] Various features and associated advantages are described for
diametrically adjustable support structures, adjustable valve
structures, removable/replaceable valve structures, and associated
systems and methods. Various examples of prosthetic valves suitable
for implantation in a body conduit of a patient (e.g., a natural
heart valve orifice, pulmonary artery, or aortic artery) that is
susceptible to changes in diameter over time (e.g., as a result of
patient growth, degenerative conditions such as an enlarged heart,
or other causes). Although some examples are directed toward
prosthetic valve that is a conduit having a valve structure, or a
"valved conduit" (e.g., used to replace a pulmonary valve and a
portion of the corresponding pulmonary artery or an aortic valve
and the aortic root), and other examples are directed toward
prosthetic valves implanted in native valve orifices (e.g., to
replace an aortic or mitral valve), the features and advantages of
the structures associated with those examples are interchangeable
regardless of a particular application for which the examples are
described.
[0165] In each of the described embodiments, it is contemplated
that the various diametric adjustment features of the embodiments
facilitate a change (increase) in diameter from a first active
state at a first diameter to another active state at a second,
larger diameter, wherein the increase in diameter of a desired
amount. For example, it is expressly contemplated that the various
diametric adjustment features for each of the embodiments may
achieve a change in diameter between first and second active, or
operative diameters of at least 10%, at least 20%, at least 30%, at
least 50%, at least 100%, at least 200% or more as well as any and
all ranges and values between each of the foregoing values (e.g.,
15% or between 10% and 200%). These values are provided as examples
only, and designs configured to achieve smaller or greater
diametric adjustability are also contemplated.
[0166] Although the embodiments addressed herein may be described
in connection with various principles and beliefs, the described
embodiments should not be bound by theory. For example, various
examples are described in connection with prosthetic valves used in
cardiac applications, although the features and concepts of this
disclosure can be applied toward any prosthetic valve of similar
structure and/or function, including non-cardiac applications.
Terminology and Definitions
[0167] As the terms are used herein with respect to ranges of
measurements "about" and "approximately" may be used,
interchangeably, to refer to a measurement that includes the stated
measurement and that also includes any measurements that are
reasonably close to the stated measurement, but that may differ by
a reasonably small amount such as will be understood, and readily
ascertained, by individuals having ordinary skill in the relevant
arts to be attributable to measurement error, differences in
measurement and/or manufacturing equipment calibration, human error
in reading and/or setting measurements, adjustments made to
optimize performance and/or structural parameters in view of
differences in measurements associated with other components,
particular implementation scenarios, imprecise adjustment and/or
manipulation of objects by a person or machine, and/or the like. In
the event it is determined that individuals having ordinary skill
in the relevant arts would not readily ascertain values for such
reasonably small differences, the terms "about" and "approximately"
can be understood to mean plus or minus 10% of the stated
value.
[0168] Certain terminology is used herein for convenience only. For
example, words such as "top", "bottom", "upper," "lower," "left,"
"right," "horizontal," "vertical," "upward," and "downward" merely
describe the configuration shown in the figures or the orientation
of a part in the installed position. Indeed, the referenced
components may be oriented in any direction. Similarly, throughout
this disclosure, where a process or method is shown or described,
the method may be performed in any order or simultaneously, unless
it is clear from the context that the method depends on certain
actions being performed first. Various terms may be called out in a
manner that indicates they may be used interchangeably in the
following description. For example, the terms "auxiliary leaflet"
and "secondary leaflet" are used interchangeably.
Description of Various Embodiments
[0169] FIG. 1 shows a prosthetic valve 100, also described as a
valved conduit 100, according to some examples. The prosthetic
valve 100 includes a support structure 102 (optionally described as
a conduit 102 according to some examples) with a valve structure
104 (indicated generally by a box in broken lines) arranged within
the support structure 102. The support structure 102 may include an
upstream end (also described as an inflow end) and a downstream end
(also described as an outflow end) and the valve structure 104 may
be configured to allow flow in one direction through the prosthetic
valve 100 (e.g., from the upstream end to the downstream end) while
inhibiting or preventing flow in an opposite direction (e.g., from
the downstream end to the upstream end).
[0170] The prosthetic valve 100 may be used, in a non-limiting
example, as a shunt for connecting the right ventricle to the
pulmonary artery following a Norwood operation, as frequently
performed for the treatment of hypoplastic left heart syndrome
(HLHS). In some examples, the prosthetic valve 100 is indicated for
the correction or reconstruction of the right ventricle outflow
tract (RVOT) in pediatric patients or application in any of a
variety of heart disorders. For example, the prosthetic valve 100
may be utilized in other areas of the heart (e.g., in repair or
replacement of the native aortic or mitral valves) or even other
areas of the body (e.g., in the venous system, the biliary system,
or elsewhere in the body).
[0171] In various examples, the support structure 102 is tubular in
shape and configured as a conduit for bodily fluids (e.g., blood).
The support structure 102 may include a graft or similar tubular
conduit, a frame or similar construct (e.g., a stent), or
combinations thereof. The support structure 102 may be
diametrically expandable (e.g., self-expanding or expandable upon
application of a radial expansion force).
[0172] FIG. 2 illustrates an interior downstream view of the valve
structure 104 in a closed configuration. The valve structure 104
includes one or more leaflets 106 that extend into an interior of
the support structure 102. Although three leaflets 106 are shown in
FIG. 2, the valve structure 104 may include one, two, four, five,
six, seven, eight or any number of leaflets 106. As shown in FIG.
2, the leaflets 106 close toward a center 108 of the support
structure 102 when in the closed configuration. In an open
configuration, fluid may flow through the valve structure 104 with
the leaflets 106 being forced toward an inner surface 110 of the
support structure 102. Generally, the valve structure 104 is
coupled to and/or extends from the inner surface 110 of the support
structure 102.
[0173] The leaflets 106 are coupled or attached to the support
structure 102 to define the valve structure 104. The term
"coupled," as used herein, means joined, connected, attached,
adhered, affixed, or bonded. In examples using adhesion, the
leaflet(s) 106 are adhered to an interior and/or exterior surface
of the support structure 102 by an adhesive, thermal bonding, or
chemical bonding as desired. Regardless, some portion of each
leaflet 106 is coupled to the support structure 102. As shown in
FIG. 2 gaps 112 may be provided between each of the leaflets 106 if
desired, which can help allow some limited backflow through the
valve structure 104. Such backflow may lessen the opportunity for
blood to stagnate behind the leaflets 106, which may otherwise lead
to thrombus formation. In cardiac applications, such as pulmonary
valve conduit replacement, the gaps 112 can be sized such that
leakage resulting from the backflow is minimal and does not
otherwise increase strain on the patient's heart to pump blood
through the prosthetic valve 100. In some examples, the prosthetic
valve 100 does not include gaps 112 at a first inner diameter, and
then, following diametric expansion, the gaps 112 existing between
the leaflets 106 at a second, larger inner diameter as a result of
the expansion. In a related aspect, in some examples, the gaps 112
exist at a first width at the first inner diameter and are enlarged
as a part of diametric expansion of the prosthetic valve 100 to the
second inner diameter. Thought the gaps 112 are shown extending to
the center 108, in operation the gaps 112 may close along much of
the leaflet edges and remain open near the leaflet perimeters
adjacent the inner surface 110 of the support structure 102.
[0174] FIG. 3 is a schematic view of a first one of the leaflet(s)
106. As shown, the leaflet 106 has an attachment zone 142 around a
perimeter of the leaflet 106 corresponding to a portion of the
leaflet 106 coupled to the support structure 102. Although the
attachment zone 142 is shown as a continuous area around the
perimeter of the one or more leaflets 106, the attachment zone 142
may include one or more discontinuous areas (e.g., formed of one or
more separate tabs of material).
[0175] Each of the leaflets 106 may be coupled to the inner and/or
outer surface of the support structure 102 as desired. For example,
the support structure 102 may include one or more openings (e.g.,
slots) through which portions of the leaflets 106, such as the
attachment zone 142, may pass. Additionally, or alternatively, the
attachment zone 142 may be coupled to the inner surface of the
support structure 102 (e.g., using adhesives, thermal bonding, or
other coupling mechanism). Regardless, the attachment zone 142
generally corresponds to a portion of the leaflet 106 that is
coupled to the support structure 102 according to various examples.
The remaining portion of each of the leaflets 106 defines a base
150 of the leaflet 106, a free edge 152 of the leaflet 106, a first
commissure region 154, a second commissure region 156 and a belly
region 158. As shown in FIG. 2, each of the leaflets 106 extends
into the support structure 102 and toward the center 108 of the
support structure 102. As will be described in greater detail, each
of the one or more leaflets 106 can be sized, shaped, and otherwise
configured to permit some diametric expansion of the support
structure 102 while maintaining proper functioning of the valve
structure 104.
[0176] FIG. 4 shows an area of the support structure 102 proximate
the location of the valve structure 104 (FIG. 3). In certain
examples, the support structure 102 may be formed of materials
including expanded polytetrafluoroethylene (ePTFE), although a
variety of materials are contemplated. Though not separately shown
in FIG. 4, in some examples, the support structure 102 includes a
frame (e.g., such as those subsequently described, including those
described in association with FIGS. 36-49). As described below, the
support structure 102 (or portions thereof) is optionally
diametrically adjustable. In some examples, the prosthetic valve
100, including the support structure 102, is diametrically
expandable over time under physiologic conditions (e.g., by a creep
mechanism) and in some examples is diametrically expandable by
application of a sufficient radial expansion force (e.g., during a
transcatheter expansion procedure). Combinations of both natural,
physiologic diametric expansion mechanisms and applied, or manual
diametric expansion mechanisms are also contemplated.
[0177] As described below, one or more regions of the support
structure 102 and/or the valve structure 104 may be configured to
exhibit expansion over a greater period of time (e.g., via a creep
mechanism) that may span days, months, or years (e.g., so that the
prosthetic valve 100 adjusts diametrically in a manner that
correlates to a desired portion of a growth curve of a patient).
For reference, in any of the examples where expansion over time is
desired via creep mechanism, materials forming portions of the
prosthetic valve 100 may be naturally susceptible to creep (e.g.,
made of a material that is less resistant to creep over a
particular pressure range) or made susceptible to creep by various
techniques (e.g., by lasing, perforating, plasma treating, etching,
heat treating or otherwise modifying the physical characteristics
of the deformation regions 252).
[0178] In the case where deformation upon application of a
sufficient force is desired, materials forming portions of the
prosthetic valve 100 may be made frangible and/or plastically
deformable by various techniques. For example, materials forming
portions of the prosthetic valve 100 may include a coating,
reinforcement layer, or other feature that factures, deforms, or
otherwise releases once sufficient expansion force is applied.
Articles made of a porous material (e.g., ePTFE) having a fibrillar
microstructure of bent fibrils may be provided with a fracturable
coating (e.g., FEP) whereby the physical size (e.g.,
circumferential aspect) of the prosthetic valve 100 may be enlarged
upon application of force in a direction substantially parallel to
a direction of orientation of the fibrils (e.g., an expansion force
resulting in a tensile force in the material in a circumferential
direction). Such tensile force can result in fracturing of the
fracturable material, straightening of the bent fibrils, and a
concomitant non-recoverable diametric adjustment. Non-exclusive
examples of such suitable materials and coatings can be found in
U.S. Pat. No. 9,522,072 to Kovach et al., filed by W.L. Gore &
Associates, Inc. on Mar. 6, 2014.
[0179] As shown in FIG. 4, the support structure 102 includes a
support portion 200 and an optional conduit portion 202. In various
examples, one or more sections of the conduit portion 202 are
formed to be diametrically adjustable (e.g., over time and/or upon
application of an expansion force, as previously referenced).
Diametric adjustment features can include folds, or corrugations
(see, e.g., description of longitudinal folds), materials or
arrangements that are diametrically adjustable upon imparting
sufficient expansion force (see, e.g., description of coatings,
reinforcement layers, and/or other features that release once
sufficient expansion force is applied), and/or materials or
arrangements that account for diametric adjustment over time (see,
e.g., description of creep mechanisms), or any of a variety of
other diametric adjustment features as desired.
[0180] In various examples, the support portion 200 of the support
structure 102 corresponds to the location where the valve structure
104 is coupled to the support structure 102. Although the support
portion 200 is shown with an outline corresponding to the shape of
the attachment zone 142, it should be understood that this is a
non-limiting example, and the support portion 200 may have
alternative shapes as desired.
[0181] In FIG. 4, the support portion 200 is shown to have the
general shape of the attachment zone 142 of the leaflets 106 (e.g.,
as the attachment zone 142 would appear superimposed on the support
structure 102). As shown, the support portion 200 optionally
defines an arcuate or U-shape, with a base 212, a first leg 214, a
second leg 216, a first commissure support 218, and a second
commissure support 220. For reference, the first commissure support
218 and the second commissure support 220 operate and function as
commissure posts and as such that "post" nomenclature may be used
interchangeably for the first commissure support 218 and the second
commissure support 220.
[0182] In some examples, the support portion 200 is configured to
assist with supporting the valve structure 104 under physiologic
conditions and to resist deformation under expansion forces
imparted on the support portion 200 (e.g., radial expansion forces
from a balloon catheter or physiologic forces from blood pressure).
In some examples, the support portion 200 (or regions thereof)
includes materials that are densified, rigidified, or otherwise
treated or structured to increase resistance to instantaneous
and/or chronic deformation during operating conditions, as well as
during diametric expansion of the conduit portion 202. For
reference, densification refers to a process of selectively making
a material more dense at desired locations, such as by heating
and/or pressure. For example, in certain embodiments, the support
structure 102 is formed from ePTFE that is densified in one or more
areas to reduce porosity and make the areas more rigid.
[0183] If desired, one or more layers, coatings, and/or surface
treatments may be applied to the support portion 200 to selectively
enhance resistance to deformation. For example, fluorinated
ethylene propylene (FEP), polyether ether ketone (PEEK), and/or
other material may be applied to the support portion 200 to add
selective resistance to deformation to the support portion 200. As
still another additional or alternative option, the support portion
200 may include one or more reinforcement elements (e.g., a
continuous or discontinuous fiber, strand, bead, wire, or other
reinforcement element) to help provide selective resistance to
deformation.
[0184] Regardless of the deformation mechanism (instantaneous or
chronic), as indicated in FIG. 5 by the broken line arrows, in some
examples diametric expansion of the conduit portion 202 adjacent
the support portion 200 occurs while one or more areas of the
support portion 200 resist deformation and maintain valve structure
104 operability. This resistance to deformation can help the
support portion 200 maintain a more consistent dimension with the
attachment zones 142 (FIG. 3) while still allowing diametric
expansion of the support structure 102. In some examples, the valve
structure 104, and in particular the geometries of the one or more
leaflets 106 are selected to accommodate this diametric expansion.
For example, the leaflets 106 may include additional material in
the belly region of the leaflets 106 to accommodate a reduction in
overall height of the valve structure 104 that may occur as the
inner diameter of the support structure 102 and the diameter of the
valve structure 104 increases.
[0185] In some examples, one or more regions of the support portion
200 exhibit a desired amount of expansibility (e.g., over time
under physiologic loading and/or upon application of a sufficient
force). These regions may act as hinges or expansion zones. In
different terms, the support portion 200 may be configured to
selectively deform, or deform to a greater extent in some regions
than others. As shown in FIGS. 6 and 7, for example, the support
portion 200 optionally includes one or more resistant regions 250
and one or more deformation regions 252, or yield regions, where
the resistant regions 250 have relatively increased resistance to
deformation and the deformation regions 252 have relatively
decreased resistance to deformation so that preferential expansion
during diametric adjustment of the support portion 200 occurs at
the deformation regions 252.
[0186] Concomitant deformation of the support portion 200 may
result in a change in the saddle or U-shaped design
previously-described, such as the first commissure support 218 and
the second commissure support 220 separating, or moving away from
one another, the first leg 214 and the second leg 216 separating,
or moving away from one another, and the base 212 widening with the
overall U-shape of the support portion 200 becoming more shallow.
This widening and shallowing of the support portion 200 may
translate to the valve structure 104 or the valve structure may
similarly include decreased resistance to deformation at those
areas to match the support portion 200. Generally, the leaflets 106
may be configured to better accommodate the diametric increase and
any associated geometric shift of the support portion 200 (e.g., by
including additional material in the belly region of the leaflets
106) and/or including expansion/diametric adjustment features such
as those described in association with various examples in this
disclosure.
[0187] If desired, one or more layers, coatings, and/or surface
treatments may be applied to the support portion 200 at the
resistant regions 250 that enhance resistance to deformation at the
resistant regions 250. The one or more layers, coatings, and/or
surface treatments may be left from and not applied to the
deformation regions 252 to encourage preferential deformation at
the deformation regions 252 relative to the resistant regions 250.
For example, fluorinated ethylene propylene (FEP), polyether ether
ketone (PEEK), and/or other material may be applied to the
resistant regions 250 and left from the deformation regions 252
(and the areas of the conduit 202 around the support portion 200)
to add selective resistance to deformation to the support portion
200.
[0188] As still another additional or alternative option, as shown
in FIG. 7, the resistant regions 250 may include one or more
reinforcement elements 260 (e.g., a continuous or discontinuous
fiber, strand, bead, wire, or other reinforcement element) that
helps provide selective resistance to deformation.
[0189] Regardless, the deformation regions 252 (and/or the areas of
the conduit 202 around the support portion 200) can be configured
to be more susceptible to deformation (e.g., under a diametric
expansion force applied to the support portion 200) than the
resistant regions 210. In some examples, the deformation regions
252 are more susceptible to creep under physiologic conditions
(e.g., to permit selective diametric expansion over time) than the
resistant regions 210. Additionally or alternatively, the
deformation regions 252 may be susceptible to deformation upon
application of a sufficient expansion force (e.g., to permit
deformation by catheter balloon expansion) while being resistant to
creep. The deformation regions 220 may be made more susceptible to
creep in any of the manners previously described or configured to
permit deformation upon application of a sufficient force in any of
the manners previously described.
[0190] As referenced above, in certain embodiments, the prosthetic
valve 100 may additionally or alternatively include a support frame
(not shown) at the support portion 200 (e.g., to help prevent
unwanted or irregular compression/deformation at the valve
structure 104). Such support frames can also be configured to
support diametric adjustment of the prosthetic valve 100, as
subsequently described in various examples.
[0191] Additionally or alternatively to the aforementioned features
of the support structure 102, each of the leaflets 106 may include
one or more expansion features to accommodate expansion of the
prosthetic valve 100, and in particular diametric expansion of the
prosthetic valve 100 at the valve structure 104 and/or the support
portion 200. As shown in FIG. 8, the leaflet 106 includes a first
side region 302, a second side region 304, and a central region 306
in the operative region, or belly region 158.
[0192] Although a variety of materials are contemplated, each of
the leaflets 106 may include a composite material comprising an
expanded fluoropolymer membrane (e.g., ePTFE) and an elastomer or
elastomeric material. It should be appreciated that multiple types
of fluoropolymer membranes and multiple types of elastomer or
elastomeric materials can be combined to form a suitable composite
material. Additional or alternative suitable biocompatible polymers
include, but are not limited to, urethanes, silicones
(organopolysiloxanes), copolymers of silicon-urethane,
styrene/isobutylene copolymers, polyisobutylene,
polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon
copolymers, fluorinated hydrocarbon polymers and copolymers or
mixtures of each of the foregoing.
[0193] In some examples, each of the leaflets 106 is configured to
account for some of the change in shape of the support portion 200
so that the valve structure 104 still properly functions over
multiple inner diameters as the support portion 200 is deformed.
For example, the belly region 158 of each of the leaflets 106 may
be relatively deeper (e.g., bend further inwardly into the valve)
prior to diametric expansion, with the belly region 158 becoming
more shallow to account for diametric expansion and the change in
shape of the support portion 200 (e.g., as shown in FIG. 5). Thus,
the leaflets 106 can have geometry that is pre-selected to
accommodate diametric expansion (including the ability to
accommodate a somewhat elongated geometry at a smaller diameter and
a shallower belly geometry at a larger diameter). Stated
differently, the geometry of the leaflets 106 may be predetermined
to allow leaflet deformation to accommodate the increase in
diameter.
[0194] Additionally or alternatively, the overall geometry of the
valve structure 104 can be changed or adjusted during expansion of
the prosthetic valve 100, such that as the inner diameter of the
prosthetic valve 100 increases and thus the diameter of the valve
structure 104 increases, each of the leaflets 106 accommodates the
change in diameter by increasing in operative size. In particular,
the leaflets 106 may have one or more portions (contained,
inoperable, or inactive portions) that are expansible, adjustable,
or deployable from a stored condition (contained, inoperable, or
inactive state) to a released condition (exposed, operable, or
active state) to accommodate diametric expansion of the valve
structure 104.
[0195] In some examples, one or more of the first side region 302,
the second side region 304, and the central region 305 (including
portions thereof) are releasably secured to the support structure
102 such that the leaflet 106 has a first geometry (e.g., the
actuating portion of the leaflet 106 has a first size/shape)
suitable for operation of the valve structure 104 at a first inner
diameter and upon release from the support structure 102 during
diametric enlargement of the prosthetic valve 100 the leaflet 106
takes on a second geometry (e.g., the actuating portion of the
leaflet 106 has a second, larger size/shape) suitable for operation
of the valve structure 104 at a second, larger inner diameter.
[0196] As non-liming examples, the first side region 302, the
second side region 304, and/or the central region 306 (or portions
thereof) may be releasably secured to the support structure by any
of a variety of means, including a fracturable coating or adhesive,
a biodegradeable adhesive, a breakable fastener (e.g., a suture), a
biodegradeable fastener (e.g., a suture), or by other means such
that the secured portion(s) are freed upon imparting a sufficient
expansion force on the prosthetic valve 100 and/or after sufficient
time passes for biodegradable features to biodegrade.
[0197] In some examples, one or more of the first side region 302,
the second side region 304, and the central region 306 (or portions
thereof) include one or more folds 350 (shown generally in FIG. 9),
or corrugations, that are secured together (e.g., by a fracturable
coating, a biodegradeable adhesive, a breakable fastener, a
biodegradeable fastener, or other means) such that the folds are
freed upon imparting a sufficient expansion force on the prosthetic
valve 100 and/or after sufficient time passes for biodegradable
features to biodegrade. Again, the folds 350 can facilitate the
leaflet 106 transitioning from a first geometry (e.g., the
actuating portion of the leaflet 106 has a first size/shape)
configured for operation of the valve structure 104 at a first
inner diameter and upon release of the one or more folds 350, the
leaflet 106 takes on a second geometry (e.g., the actuating portion
of the leaflet 106 has a second, larger size/shape) configured for
operation of the valve structure 104 at a second, larger inner
diameter.
[0198] In some examples, one or more of the first side region 302,
the second side region 304, and the central region 306 (or portions
thereof) include an expansible material 352 (shown generally in
FIG. 10), such as one of the material arrangements previously
described that are configured to facilitate creep over time or
expansion upon exceeding a requisite expansion force. Again, the
expansible material can facilitate the leaflet 106 transitioning
from a first geometry configured for operation of the valve
structure 104 at a first inner diameter and upon expansion of the
expansible material 352, the leaflet 106 takes on a second (e.g.,
larger) geometry suitable for operation of the valve structure 104
at a second, larger inner diameter.
[0199] FIGS. 11-13 show additional or alternative diametric
expansion features for the prosthetic valve 100. As shown, the
support structure 102 includes one or more longitudinal folds, such
as a first longitudinal fold 402 and a second longitudinal fold 404
that are releasable to permit diametric expansion of the prosthetic
valve 100. Longitudinal folds may be incorporated at the areas
corresponding to each of the commissure regions of the valve
structure 104 as desired. Such longitudinal folds are releasably
secured together by any of a variety of means, including using a
fracturable coating, a biodegradeable adhesive, a breakable
fastener (e.g., a suture), a biodegradeable fastener (e.g., a
suture) or other means such that the folds are freed upon imparting
a sufficient expansion force on the prosthetic valve 100 and/or
after sufficient time passes for biodegradable features to
biodegrade.
[0200] In some examples, the first side region 302 is secured
within the first longitudinal fold 402 when the prosthetic valve
100 and in particular the valve structure 104 is at a first inner
diameter (FIG. 12) and/or the second side region 304 is secured
within the second longitudinal fold 404 when the prosthetic valve
100, and in particular the valve structure 104, is at the first
inner diameter. Upon release of the first longitudinal fold 402 and
the second longitudinal fold 404, the prosthetic valve 100 and in
particular the valve structure 104 increases to a second, larger
inner diameter (not shown), where the first side region 302 and the
second side region 304 of the leaflet 106 are made available and
the operative shape, or geometry, of the leaflet 106 is increased
to account for the increase in inner diameter.
[0201] Some examples include the ability to increase leaflet size
by storing portions of the leaflet 106 in folds, such as the first
longitudinal fold 402 and the second longitudinal 404. Such
longitudinal folds may also be employed for facilitating expansion
of the support portion 102 while other features are incorporated
for the valve structure 104 to account in the diametric change,
including any of those features previously described for the
support portion 200. For example, the leaflets 106 may include
folds, such as folds 350 or expansible material, such as expansible
material 352, independently from the support portion 102 that are
releasable to account for diametric expansion of the prosthetic
valve 100. Stated differently, it is contemplated that the various
expansion features referenced for the leaflets 106 may be employed
for the support structure 102, and vice versa.
[0202] FIGS. 14-16 show additional or alternative diametric
expansion features for the prosthetic valve 100. As shown, the
support structure 102 includes one or more longitudinal folds, such
as the first longitudinal fold 402 and the second longitudinal fold
404 that are releasable to perm it diametric expansion of the
prosthetic valve 100. Again, such longitudinal folds are releasably
secured together by any of a variety of means, including any of
those previously described.
[0203] According various examples, such as that of FIGS. 14-16, a
leaflet storage concept may be applied to the prosthetic valve 100
with added, or auxiliary leaflets (also described as secondary
leaflets) that are initially contained (stored, or hidden) in an
inoperable or inactive state by the prosthetic valve 100 (e.g.,
within a fold or other appendage of the prosthetic valve 100) such
that when the valve diameter is increased, the stored auxiliary
leaflet(s) are released and added to the complement of original
leaflets to an operable or active state. In various examples, the
commissure region where two original leaflets attach provides a
potential location for attachment and storage of such auxiliary
leaflets. In some such examples, when the inner valve diameter is
increased, the commissure region splits apart, and the auxiliary
leaflet 106a is deployed between the original leaflets
(interchangeably described as "primary leaflets") at the
split-apart commissure region. Additional examples of such
auxiliary leaflet possibilities include a bileaflet arrangement
(i.e., two leaflets 106) with an auxiliary leaflet 106a within a
fold that is released and exposed to transfer the prosthetic valve
100 from a two-leaflet valve to a three-leaflet valve upon
diametric expansion.
[0204] As indicated in FIGS. 14-16, an auxiliary leaflet 106a
(e.g., similar to the original, or primary leaflet(s) 106, or
larger or smaller than the original, or primary leaflet(s) 106) can
be stored within the first longitudinal fold 402 and/or another
auxiliary leaflet 106a can be stored within the second longitudinal
fold 404 when the prosthetic valve 100 and in particular the valve
structure 104 is at a first inner diameter (FIG. 15). Though not
shown, any number of folds and associated auxiliary leaflets are
contemplated.
[0205] As shown, the first longitudinal fold 402 and the second
longitudinal fold 404 are positioned at locations along the support
portion 200 corresponding generally to commissure regions 116
between the leaflets 106. The auxiliary leaflet(s) 106a are
attached at commissure regions 116 between the leaflets 106. Upon
release of the first longitudinal fold 402 and the second
longitudinal fold 404, the commissure regions 116 each split in two
as the prosthetic valve 100 and in particular the valve structure
104 transitions to a larger, second inner diameter (FIG. 16). Upon
splitting, of the commissure regions 116 and opening of the first
longitudinal fold 402, the second longitudinal fold 404 and any
other folds (e.g., a third fold, though not shown), the auxiliary
leaflet(s) 106 are released and are made available to coapt with
the leaflets 106 to form part of the valve structure 104 and
account for the increased inner diameter.
[0206] If desired, similar arrangements (e.g., a longitudinal fold
and stored auxiliary leaflet) can be supplied between each of the
leaflets 106 to provide a desired amount of diametric adjustment
capability. Thus, in the example of FIGS. 14-16, the number of
leaflets 106 may effectively double as a part of diametric
expansion. Similar principles may be applied to increase the
effective number of leaflets as desired.
[0207] Although some examples include the ability to increase an
operative inner diameter of the valve structure 104 by storing one
or more auxiliary leaflets in the support structure 102, it should
be understood that such longitudinal folds may be employed for
diametric adjustment of the support structure 102 and the leaflets
106 may be configured to account for the diametric increase in any
of the manners previously described. If desired, the leaflets 106
themselves may include folds (e.g., such as folds 350) in the first
side region 302 and/or second side region 304 of each of the
leaflets 106 to store one or more of the auxiliary leaflets 106a
that can be released during diametric adjustment to account for the
increase in diameter of the valve structure 104. In such examples,
the effective number of leaflets is increased (e.g., doubled,
tripled, etc.) when transitioning from the smaller valve diameter
to the larger valve diameter.
[0208] FIGS. 17-20 show additional or alternative diametric
expansion features for the prosthetic valve 100. As shown, the
support structure 102 includes one or more longitudinal folds that
are releasable to permit diametric expansion of the prosthetic
valve 100, such as the first longitudinal fold 402 in the position
shown in FIG. 17. Such longitudinal folds are releasably secured
together by any of a variety of means, including any of those
previously described. The prosthetic valve 100 optionally includes
any number of folds, including a fold extending longitudinally
along the support structure 102 at a location generally
corresponding to a center of each of the leaflets 106.
[0209] In various examples, the central region 306 of the leaflet
106 is stored within the first longitudinal fold 402 when the
prosthetic valve 100 and in particular the valve structure 104 is
at a first inner diameter (FIG. 18) and the first side region 302
and the second side region 304 remain exposed inside the support
structure 102 to form sub-leaflets 106b that are each smaller than
overall geometry of the leaflet 106. Upon release of the first
longitudinal fold 402, the prosthetic valve 100 and in particular
the valve structure 104 transitions to a larger, second inner
diameter (FIG. 20), where the central region 306 is released and
the sub-leaflets 106b transition into the leaflet 106, which is
larger, and includes the central region 306, to form part of the
valve structure 104 and account for the increased inner diameter.
If desired, similar arrangements (e.g., a longitudinal fold and
stored auxiliary leaflet) can be supplied for each of the leaflets
106 to provide a desired amount of diametric adjustment capability.
In such examples, the effective number of leaflets is reduced
(e.g., halved) when transitioning from the smaller valve diameter
to the larger valve diameter.
[0210] Although some examples include the ability to increase an
operative inner diameter of the valve structure 104 by storing the
central region(s) 306 of the leaflet(s) 106 in folds, such as the
first longitudinal fold 402, it should understood that such
longitudinal folds may be employed for diametric adjustment of the
support structure 102 and the leaflets 106 may be configured to
account for the diametric increase in any of the manners previously
described. If desired, the leaflets 106 themselves may include
folds (e.g., such as folds 350) in the central region 306 of each
of the leaflets 106 such that the leaflets 106 initially provide
one or more sub-leaflets 106b and, upon release of the folds,
release the central region 306 to fully form the leaflets 106 as
shown in FIG. 20 to account for diametric adjustment.
[0211] FIGS. 21-23 show additional or alternative diametric
expansion features for the prosthetic valve 100. In various
examples, the prosthetic valve 100 is provided with an inflow
and/or outflow portion that can increase in diameter as needed,
while the support portion 200 and the valve structure 104 remain at
a constant diameter. In certain instances, flow dynamics in a
smaller conduit is desirable and, at some point in time, the flow
dynamics of a larger conduit may be desirable.
[0212] As shown in FIGS. 21-23, the support portion 200 and the
valve structure 104 are optionally formed at a larger inner
diameter and one or more sections of the conduit portion 202 (e.g.,
inflow end portion 502 and/or outflow end portion 504) are formed
at a smaller inner diameter and are diametrically adjustable as
desired (upon exceeding a requisite diametric adjustment force
and/or over time under physiologic conditions). Any of the features
for facilitating diametric adjustment described herein (fracturable
coatings, creep mechanisms, biodegradable features, folds,
compression layers, etc.) are applicable for diametric adjustment
of the inflow end portion 502 and/or outflow end portion 504.
[0213] FIGS. 24-25 show additional or alternative diametric
expansion features for the prosthetic valve 100. As shown in FIGS.
24-25, the support portion 200 includes a leaflet storage and
release mechanism by which portions of the valve structure 104 are
initially stored when the prosthetic valve 100 is at a first inner
diameter (FIG. 24) and then made available as the prosthetic valve
100 is transitioned to a second, larger inner diameter (FIG.
25).
[0214] As shown, the support portion 200 includes an outer layer
602, a compression layer 604, and an inner layer 606. The support
portion 200 is configured to retain and store one or more stored
portions 608 of the one or more leaflets 106 between the outer
layer 602 and the inner layer 606. In some examples, the leaflets
106 are secured to the outer layer 602 and/or the compression layer
604.
[0215] The inner layer 606 is capable of expanding outwardly
against the compression layer 604, and the outer layer 602
optionally resists outward deformation such that the compression
layer 604 is radially collapsed. The outward expansion of the inner
layer 606 effectively increases the operating inner diameter of the
prosthetic valve 100.
[0216] The compression layer 604 optionally includes one or more
struts, biasing elements or other features that helps maintain
spacing between the inner layer 606 and the outer layer 602. This
spacing helps ensure that the stored portion 608 does not pull out
during operation of the leaflets 106 when the prosthetic valve 100
is at the first inner diameter.
[0217] As the prosthetic valve 100 is transitioned to the second,
larger inner diameter (FIG. 25) the compression layer 604 collapses
and the stored portions 608 of the leaflets 106 are revealed or
otherwise exposed to adjust the geometry of the one or more
leaflets 106 to account for the change in inner diameter of the
prosthetic valve 100. The stored portions 608 remain detached, or
are detachable from the inner layer 606 during diametric expansion
so that the stored portions 608 are able to be released from
between the outer layer 602 and inner layer 606 to extend from the
inner surface of the prosthetic valve 100 following diametric
expansion of the prosthetic valve 100, and in particular during
expansion of the inner diameter of the prosthetic valve 100.
[0218] Again, any of the features for facilitating diametric
adjustment (fracturable coatings, creep mechanisms, biodegradable
features, folds, compression layers, etc.) are applicable for
diametric adjustment of the inner layer 606 and/or the conduit
portion 202 to increase the effective inner diameter of the
prosthetic valve 100.
[0219] FIGS. 26-27 show additional or alternative diametric
expansion features for the prosthetic valve 100. For example, as
indicated in FIGS. 26-27, the compression layer 604 is optionally a
layer of material that extends along a portion of the length of the
prosthetic valve 100 (e.g., the entire, or the majority of the
length). As previously referenced, the inner layer 606 and the
outer layer 602 are optionally formed of any of the materials
previously described for the support structure. Generally the outer
layer 602 is resistant to distension or radial deformation, while
the inner layer 606 is configured to be radially expanded (e.g.,
deformed). The compression layer 604 is optionally formed of a
compressible material and/or otherwise defines a compressible
space.
[0220] The inner layer 606 is again capable of expanding outwardly
against the compression layer 604 while the outer layer 602 resists
outward deformation such that the compression layer 604 is radially
collapsed. Again, the outward expansion of the inner layer 606
effectively increases the operating inner diameter of the
prosthetic valve 100.
[0221] In the example of FIGS. 26-27, the compression layer 604 can
include a compressible material (e.g., foam or porous materials)
and/or an incompressible material (e.g., liquid) that is expelled
from the compression layer 604 (e.g., by diffusion and/or by being
forced through the inner layer 606 and/or outer layer 602 under
pressure). Similarly to the examples described in association with
FIGS. 24-25, the compression layer 604 may include discrete
mechanical elements (e.g., springs, struts, or other features) that
are compressible under a radial expansion force on the prosthetic
valve 100.
[0222] Again, in the example of FIGS. 26-27, the support portion
200 defines a leaflet storage and release mechanism by which stored
portions 608 of the valve structure 104 are initially stored (e.g.,
between the outer layer 602 and the inner layer 606) when the
prosthetic valve 100 is at a first inner diameter (FIG. 26) and
then made available for adjusting the geometries of the one or more
leaflets 10 as the prosthetic valve 100 is transitioned to a
second, larger inner diameter (FIG. 27).
[0223] In some examples, the one or more leaflets 106 are secured
to the outer layer 602 at the support portion 200. Initially, the
prosthetic valve 100 is at a first inner diameter and, upon
expansion of the inner layer 606 (e.g., by applying a radially
outward expansion force to the inner layer 606), the compression
layer 604 is compressed and the stored portions 608 of the leaflets
106 are revealed or otherwise made available to adjust leaflet
geometry for operatively sealing the larger inner diameter.
Generally, the stored portions 608 remain detached, or are
detachable from the compression layer 604 and the inner layer 606
so that the stored portions 608 are able to be freed for actuation
following diametric expansion of the inner diameter of the
prosthetic valve 100.
[0224] Again, any of the features for facilitating diametric
adjustment (fracturable coatings, creep mechanisms, biodegradable
features, folds, compression layers, etc.) are applicable for
diametric adjustment of the inner layer 606 and the support
structure 102 in general.
[0225] FIGS. 28-30 show additional or alternative diametric
expansion features for the prosthetic valve 100. Generally, the
prosthetic valve 100 includes a first prosthetic valve 100a and a
second prosthetic valve 100b, where the first prosthetic valve 100a
is secured within the second prosthetic valve 100b. The second
prosthetic valve 100b has larger inner diameter than the first
prosthetic valve 100a such that the first prosthetic valve 100a can
be nested inside the second prosthetic valve 100b. The smaller,
first prosthetic valve 100a may be removed from the larger, second
prosthetic valve 100b when needed. In some examples, removal may be
facilitated by the ability to evert and peel the smaller, first
prosthetic valve 100a from within the larger, second prosthetic
valve 100b. Although an arrangement of two valve structures is
shown and described, it should be understood that any number of
prosthetic valves (three, four, six, etc.) may be employed as
desired.
[0226] The first prosthetic valve 100a defines an inner diameter
and includes a support structure 102a and a valve structure 104a
operatively coupled to the support structure 102a. Prior to removal
of the first prosthetic valve 100a, the valve structure 104a is in
an active state. The first prosthetic valve 100a optionally
includes similar features and functions as the prosthetic valve
100, including any of the previously-described support and valve
structures.
[0227] The second prosthetic valve 100b also includes a support
structure 102b and a valve structure 104b which may include
features similar to those of any of the previously-described
support structures and valve structures. As shown, the second
prosthetic valve 100b includes a support layer 702b which may be
coupled to the valve structure 104b and an intermediate layer 704a
disposed inside of the support layer 702b. Prior to removal of the
first prosthetic valve 100a, the valve structure 104b is in an
inactive state, according to some examples.
[0228] In some examples, the intermediate layer 704a is releasably
coupled to the support structure 102a of the first prosthetic valve
100a. The support structure 102a optionally includes one or more
release features (not shown), such as tabs, perforations, fibers,
or other means for exerting a tension force on the support
structure 102a to release and remove the first prosthetic valve
100a from the interior of the second prosthetic valve 100b. As
previously referenced, the support structure 102a is optionally
retracted and everted as indicated by the curved, broken arrows in
FIG. 28, resulting in a peeling action/force that releases and
removes the first prosthetic valve 100a from the intermediate layer
704a of the second prosthetic valve 100b. In other examples, the
intermediate layer 704a can release from the second prosthetic
valve 100b and be removed with the first prosthetic valve 100a.
[0229] FIG. 29 shows the second prosthetic valve 100b after the
first prosthetic valve 100a has been removed from within the first
prosthetic valve 100a with the valve structure 104b in an active
state. As shown, part of the valve structure 104b is optionally
retained between the intermediate layer 704b and the support
structure 102a of the first prosthetic valve 100a such that, upon
removal of the first prosthetic valve 100a from the second
prosthetic valve 100b, the valve structure 104b is operatively
exposed to open and close within the support structure 102b. If
desired, the effective inner diameter of the second prosthetic
valve 100b defined by the intermediate layer 704b may be close to
that of the first prosthetic valve 100a so that a drastic change in
inner diameter (e.g., greater than 15%, greater than 20%, or
greater than 50%) is not exhibited at the time of removal of the
first prosthetic valve 100a. Alternatively, the intermediate layer
704b may be removed at the same time as, or close in time to, the
first prosthetic valve 100a.
[0230] As an additional feature, if desired, the intermediate layer
704b optionally retains stored portions 608b of the valve structure
104b so that the second prosthetic valve 100b is configured to
operate at an inner diameter that is close to that the prosthetic
valve 100 operated at prior to removal of the first prosthetic
valve 100a. In some examples, the intermediate layer 704b is
compressible (e.g., formed of a compressible material) and/or
removable over time (e.g., formed of a biodegradable material) to
increase the inner diameter of the second prosthetic valve 100b and
reveal the stored portions 608b of the valve structure 104b such
that the valve structure 104b adjusts in geometry to accommodate
the increased inner diameter as shown in FIG. 30.
[0231] Any of the features for facilitating diametric adjustment of
the first prosthetic valve 100a and/or and second prosthetic valve
100b (fracturable coatings, creep mechanisms, biodegradable
features, folds, compression layers, etc.) may additionally or
alternatively be employed as desired.
[0232] FIGS. 31-34 show additional or alternative diametric
expansion features for the prosthetic valve 100. Generally, such
features can include a "fish gill" arrangement in which each of the
one or more leaflets 106 has multiple, separate components that
define overlap regions, where the multiple separate components
slide relative to each other during expansion, but remain in an
overlapping configuration following expansion to accommodate an
increase in diameter of the prosthetic valve 100. In different
terms, the components are in operable engagement with one another
when the prosthetic valve 100 is at a first diameter at which the
prosthetic valve 100 is configured to be implanted to allow fluid
flow through the prosthetic valve 100 in a first direction and
inhibit fluid flow through the prosthetic valve in an opposite,
second direction, and the components are configured to be in
operable engagement with one another when the prosthetic valve 100
is at a second diameter that is larger than the first diameter by
sliding relative to each other thereby reducing the width of the
overlap region as the diameter of the prosthetic valve 100 is
increased.
[0233] In the example of FIGS. 31-34, there are two overlap
regions, one on each side of the leaflet 106, since the expansion
of the prosthetic valve 100 is in the radial direction, although
any number of components and overlap regions are contemplated in
order to accomplish a larger effective leaflet geometry following
diametric expansion of the prosthetic valve 100.
[0234] As shown in FIG. 31, the one or more leaflets 106 includes
cut outs or openings at the first side region 302 and the second
side region 304. These cut outs or openings may assist with
diametric expansion of each of the leaflets 106, and thus the valve
structure 104. For example, the cut outs may act as reliefs that
allow outward widening of the leaflets 106.
[0235] Each of the one or more leaflets 106 further includes one or
more overlap components 106g (FIG. 32). These overlap components
106g (also described as a second component or a gill component) are
similarly attached to the support structure (e.g., along an
attachment zone 142g at a perimeter of the overlap component 106g).
The overlap components 106g are optionally formed of similar
materials to the leaflets 106 or different materials as desired. In
various examples, the overlap components 106g are able to slide
over the leaflets 106 during diametric expansion while still
remaining in operable engagement with the leaflets 106 when the
valve structure 104 is closed, thus facilitating adjustment of the
valve structure 104 to diametric expansion of the prosthetic valve
100. In general terms, the width of the overlap region between the
overlap components 106g and the leaflets 106 is reduced as the
inner diameter of the prosthetic valve 100 is increased.
[0236] As shown in FIG. 33, each of the leaflets 106 acts as a
first component and each of the overlap components 106g acts as a
second component overlapping a corresponding one of the leaflets
106. FIG. 34 also shows the overlap components 106g interacting
with the leaflets 106 as viewed from an interior downstream view of
the prosthetic valve 100. In the example shown, there are two
overlap components 106g for each of the leaflets 106 corresponding
to the first side region 302 and the second side region 304 of the
leaflets 106. In this manner, the prosthetic valve 100 includes a
first leaflet component in the form of the leaflet 106 and one or
more second leaflet components in the form of the overlap
components 106g that are disposed downstream of and at least
partially overlapping the first leaflet component. The arrangement
defines an overlap region between the overlap components 106g and
the leaflets 106 that has a width, where the leaflets 106 and the
associated overlap components 106g are in operable engagement
configured to allow forward fluid flow through the prosthetic valve
100 in a first direction extending downstream and prevent
retrograde fluid flow through the prosthetic valve 100 in an
opposite direction. Any of a variety of positions of the overlap
components 106g is contemplated, including additional or
alternative overlap components positioned at the base 150 of the
leaflets 106.
[0237] FIGS. 35A-35B are illustrative of a method of forming a
prosthetic valve 100 that is diametrically adjustable, according to
some examples. As shown in FIG. 35A, the prosthetic valve 100 is
initially manufactured at a maximum desired diameter with the valve
structure 104 configured to close, or coapt in a desired manner.
The prosthetic valve 100 then undergoes a diametric compaction
process in which the diameter of prosthetic valve 100, and
particularly the diameter of the inner lumen of the prosthetic
valve 100, is decreased as shown in FIG. 35B.
[0238] As part of the diametric compaction process, portions of the
leaflets 106 (e.g., the side regions) are reversibly attached to
the inner surface 110 of the prosthetic valve 100 such that the
unbonded leaflet portions, or free leaflet portions are retained at
a desired size for the smaller diameter that perm its coaptation of
the valve structure 104. Leaflet attachment may be achieved via a
variety of means, including utilizing heat treatments,
fluoropolymer adhesives/materials (e.g., FEP, PATT, PATT-OH,
low-melt FEP, or others), or by other means.
[0239] In some examples, the diameter of prosthetic valve 100, and
in particular the support structure 102, is decreased as part of a
material retraction process. For example, where the support
structure is formed of a material including a fibril structure
(e.g., ePTFE) a process of forming bent or S-shaped fibrils can be
employed via retraction of the fibril structure and a coating of an
elastomeric material (e.g., FEP). Examples of suitable retraction
processes and materials can be found in U.S. Pat. No. 9,522,072 to
Kovach et al., filed by W.L. Gore & Associates, Inc. on Mar. 6,
2014.
[0240] In some examples, unwanted-, or over-dilation, of the
prosthetic valve 100 when transitioning back from the diametrically
compacted state to the diametrically enlarged state can be
prevented by providing the prosthetic valve 100 with a film that
provides a relatively high elongation resistance in a
circumferential direction of the prosthetic valve 100 when the
prosthetic valve 100 is at the enlarged diameter.
[0241] The prosthetic valve 100 is configured to be diametrically
enlarged while maintaining the ability of the valve structure 104
to properly coapt. In order to facilitate such adjustability, as a
general matter, often times there is a leaflet bonding length to
diametric compaction ratio of the support structure that provides
the ability of the valve structure 104 to coapt at a desired
diameter. In some examples, the valve structure 104 resists tensile
deformation such that, upon diametric expansion of the prosthetic
valve 100, portions of the valve structure 104 that are secured to
the support structure 102 pull away from the support structure and
are freed, or released, to accommodate the increase in diameter and
maintain the ability to coapt properly. In some implementations,
the prosthetic valve 100 is able to be adjusted over a wide range
of diameters with the valve structure 104 freeing itself from the
support structure 102 along with the diametric expansion, and thus
permitting the valve structure 104 to properly coapt at a variety
of increasing diameters to which the prosthetic valve 100 is
adjusted.
[0242] The foregoing examples have largely been described without
regard to an associated frame, such as those commonly employed in
surgical prosthetic valves or transcatheter prosthetic valves. As
previously referenced, the prosthetic valve 100 according to any of
the preceding examples optionally includes an adjustable frame (not
shown). In various examples, the adjustable frame has adjustment
features, such as zig-zags or bends, that allow for expansion;
sliding components that allow for frame expansion and resist
collapse with ratchets or stops, for example; frangible elements
that fracture to allow for self-expansion; inner and outer frame
components, where the outer frame is diametrically adjustable with
sufficient resistance to collapse to provide support at both
smaller and larger diameters, or other adjustment features,
including any of those described below.
[0243] FIGS. 36-39 show a prosthetic valve 1100 according to
various examples. The prosthetic valve 1100 includes an adjustable
frame 1102, also described as a support structure 1102, and a valve
structure 1104 including one or more leaflets 1106 (individually
referred to as 1106a, 1106b, 1106c). In some examples, the
prosthetic valve 1100 can be increased in diameter by a factor of
two, for example, although any of a variety of diametric adjustment
factors are contemplated.
[0244] Features of the prosthetic valve 1100 may be employed in any
of a variety of applications, including pulmonary valve conduits,
surgical or transcatheter mitral, aortic, or other valve repair, or
non-cardiac applications as desired. For example, features of the
adjustable frame 1102 are optionally used with the support
structure 102 of the prosthetic valve 100 of any of the preceding
examples (e.g., in a pulmonary valve conduit application).
Similarly, any of the features of the valve structure 104 or other
features according to the preceding examples may be employed with
the prosthetic valve 1100 as desired.
[0245] The adjustable frame 1102 includes a plurality of frame
elements 1120a, 1120b, 1120c (or collectively, 1120). As shown, the
frame elements 1120 are axi-symmetric in that they are generally
similar to one another are arranged in an in an equal and opposing
manner. Although three elements are shown, any number (greater or
fewer) is contemplated.
[0246] FIG. 37 is a schematic view of one of the frame elements
1120 (the frame element 1120a) for illustration purposes. As shown,
the frame element 1120a includes a top rail 1122a, a bottom rail
1124a, a leaflet payout edge support 1126a, a primary leaflet edge
support 1128a, and a secondary leaflet edge support 1130a. Each of
the frame elements 1120 includes tabs 1150 for slidably engaging
the other frame elements 1120 (e.g., on the top rails and bottom
rails of the frame elements 1120).
[0247] The tabs 1150 are optionally in the form of hooks, clasps,
or other features that can couple and slide with adjacent frame
elements 1120. In some examples, the tabs 1150 and/or the frame
elements 1120 include retaining features (e.g., stops, ratchets,
detents, or other features) that stop relative sliding of the frame
elements 1120 at pre-selected locations. In some examples, such
features help ensure that the frame elements 1120 adjust uniformly
and equally to a desired diametric adjustment setpoint, helping to
ensure a regular geometry is imparted on the valve structure 1104
at one or more diametric setpoints. In some examples, the tabs 1150
themselves can serve as stops by interlocking with one another,
abutting one another, or otherwise interacting with one another.
FIGS. 43-45, which are referenced below, illustrate some examples
of retaining features for facilitating adjustment of the prosthetic
valve 1100 to diametric setpoints, according to some examples.
[0248] As described further below, each of the leaflets 1106 is
secured to a respective one of the frame elements 1120 in a manner
that permits leaflet material to be stored when the prosthetic
valve 1100 is a first diameter and then paid out to enlarge the
size of the valve structure 104 as the adjustable frame 1102 is
enlarged. With the example of the frame element 1120a, the material
of the corresponding leaflet 1106 is secured to the leaflet payout
edge support 1126a and the primary leaflet edge support 1128a. As
described in further detail below, the primary leaflet edge support
1128a a serves to define an operative edge of the leaflet 1106a and
another one of the frame elements 1120 (e.g., frame element 1120b)
serves to define an opposite, operative edge of the leaflet
1106a.
[0249] FIGS. 38 and 39 are flat, schematic views illustrating
relative sliding action between the frame element 1120a and the
frame element 1120b, and the concomitant adjustment of the
operative geometry of the leaflet 1106a (the operative geometry, or
the area of the leaflet that is active and actuable during valve
opening and closing, is indicated by cross-hatching on FIGS.
38-39). It should be noted that FIGS. 37-39 are flat
representations for illustration purposes and that the frame
elements 1120 are actually arranged to define a three-dimensional,
circular structure as shown in FIG. 36, for example.
[0250] As shown in the schematic view of FIG. 38, the primary
leaflet edge support 1128a of the frame element 1120a defines a
first operative edge 1160a of the leaflet 1106a and the secondary
leaflet edge support 1130b of the frame element 1120b defines a
second operative edge 1162a of the leaflet 1106a.
[0251] As shown in FIG. 39, as the frame element 1120a is slid
relative to the frame element 1120b (as would occur during
diametric expansion of the adjustable frame 1102), the primary
leaflet edge support 1128a of the frame element 1120a slides away
from the secondary leaflet edge support 1130b of the frame element
1120b, and the material of the leaflet 1106a slides over the
secondary leaflet edge support 1130b, exposing additional material
to the interior of the prosthetic valve 1100 to define a larger
operative geometry for the leaflet 1106a. In different terms, the
secondary leaflet edge support 1130b is not fixedly secured to the
material of the leaflet 1106a, but instead acts as an adjustable
support for the second operative edge 1162a.
[0252] This sliding arrangement between the frame elements 1120 and
the concomitant adjustment of the operative geometry of the
leaflets 1106 can be further observed with reference to FIGS.
40-42, which show the prosthetic valve 1100 transitioning from a
first, smaller diameter (FIG. 40) to a second, intermediate
diameter (FIG. 41), and then to an enlarged (e.g., final) diameter
(FIG. 42). As indicated in FIG. 41 by a white arrow, the material
of the leaflet 1106a is paid out from the circumference of the
prosthetic valve 1100 during adjustment to increase the operative
geometry of the leaflet 1106a during expansion.
[0253] Described in different terms, the frame elements 1120 slide
over one another to allow more of the stored or hidden material of
the leaflets 1106 ("hidden" in the sense it is not exposed for
purposes of actuation during opening and closing) to become the
active, actuable part of the leaflets 1106. This feature helps
allows the diameter of the prosthetic valve 1100 to increase and
allow the leaflets 1106 to function efficiently. The ability to pay
out, or release additional leaflet material helps allow the
leaflets 1106 to coapt and seal at various frame diameters while
minimizing redundant (or extra) material that might otherwise be
present at the point where the leaflets 1106 meet, or convergence
of the leaflets 1106 (e.g., the triple point), if the full width of
leaflet material were made available at all diameters. Such extra
material at the convergence of the leaflets 1106 may be undesirable
in that extra material can cause the leaflets not to open fully or
smoothly at the convergence of the leaflets 1106.
[0254] The operative leaflet geometries of the leaflets 1106 are
defined by the frame element 1120 to which the leaflet 1106 is
attached and by an adjacent one of the frame elements 1120. The
relative sliding motion of the frame elements 1120, and the payout
of leaflet material defining the active portion of the leaflets
1106, allows the operative edges (or the leaflet attachment lines)
of each of the leaflets 1106 to remain constant over the entire
range of diametric adjustment. As will be noted on FIGS. 40-42, a
distance from the bases of the leaflets 1106 to a center 1170 of
the valve structure 1104 (e.g., the "triple point" as shown),
remains constant so the center 1170 drops, or moves down vertically
relative to the remainder of the prosthetic valve 1100 as the
prosthetic valve 1100 increases in size diametrically.
[0255] FIGS. 43-45 show examples of retaining features that are
optionally employed to control sliding of the frame elements 1120
relative to one another. For example, as shown in FIG. 43, one or
more of the frame elements 1120 optionally include a plurality of
ratchet protections, or teeth 1120r and the tabs 1150 include a
pawl 1150p that permits sliding between the frame element 1120 and
the tab 1150 in a first direction but resists or stops relative
sliding in the opposite direction. FIGS. 44-45 show another
retaining feature option. As shown in FIG. 44, the tab 1150 is in
the form of a hook with an inward protection 1150p that is
configured as a catch, dog, or spring-operated ball, for example.
FIG. 45 shows a frame element 1102 with a plurality of seats, or
receivers 1120r along the frame element 1120. The inward projection
1150p optionally retains the tab 1150 at a desired location along
the frame element 1120 and is disengaged and allowing further
sliding of the tab 1150 along the frame element 1120 (e.g., during
diametric expansion of the valve 100) upon exceeding a particular
retaining force between the above-referenced retaining
features.
[0256] FIGS. 46-52 show an adjustable frame 2102 of a prosthetic
valve according to various examples. Features of the adjustable
frame 2102 may be employed in any of a variety of applications,
including pulmonary valve conduits, surgical or transcatheter
mitral, aortic, or other valve repair, or non-cardiac applications
as desired. For example, features of the adjustable frame 2102 are
optionally used with the support structure 102 of the prosthetic
valve 100 of any of the preceding examples (e.g., in a pulmonary
valve conduit application) and the adjustable frame 1102 of any of
the preceding examples. If desired, the adjustable frame 2102 is
configured for implantation via a surgical technique, and can then
later be diametrically adjusted to a larger diameter (e.g., using a
transcatheter balloon technique) and a second, larger diameter
prosthetic valve (not shown) can be implanted within the adjustable
frame 2102. Additionally, the adjustable frame 2102 may be dilated
(diametrically adjusted) with an associated valve structure (not
shown) configured to adjust to the increased diameter (such as a
valve structure having any of the features previously
described).
[0257] As shown the adjustable frame 2102 includes a first frame
element 2120 and a second frame element 2122. The first frame
element 2120 is optionally configured to support and be coupled to
a valve structure (not shown) and includes a plurality of split
commissure posts 2130. In some examples, the split commissure posts
2130 may provide the ability to plastically deform the first frame
element 2120 and increase the diameter of the first frame element
2120. However, such an arrangement may also result in reduced
resistance to compression of the first frame element 2120 under
physiologic loading. Regardless, in various examples the first
frame element 2120, which supports a valve structure, is
diametrically expandable, but may benefit from diametric
reinforcement during operation and/or following diametric
expansion.
[0258] The second frame element 2122 is optionally secured to the
first frame element 2120 (e.g., using one or more layers of film
material or other material) to reinforce the first frame element
2120 resistance to compression. As shown, the second frame element
2122 optionally includes a plurality of selective expansion
features 2140. As shown, the selective expansion features 2140 form
an apex, or "A" shape that allows diametric expansion when a
sufficient expansion force is exerted on the frame (e.g., using a
balloon catheter). As the apex, or A shape elongates or widens with
expansion, the shape becomes flatter and more elongate, and
naturally becomes more resistant to compressive forces on the
second frame element 2122. This, in turn, reinforces the first
frame element 2120 by virtue of its connection to the second frame
element 2122 (this connection is not shown, but is optionally
accomplished via film as previously described or other means as
desired).
[0259] FIGS. 47 and 48 show alternative or additional selective
expansion features 2150 in the form of an undulating, or sinusoidal
shaped elements. These selective expansion features 2150 that
naturally resist further compression at the initial, smaller
diameter. In particular, the selective expansion features 2150
bottom out or self-limit (e.g., the selective expansion features
2150 include surfaces that engage each other) to inhibit further
compression. This self-limiting attribute of the selective
expansion features 2150 is illustrated generally in FIG. 49 where
the sketch on the left shows one of the selective expansion
features 2150 prior to compression and the sketch on the right
shows one of the selective expansion features 2150 self-limiting
and providing a natural stop against further diametric compression.
Upon diametric expansion, the selective expansion features 2150 can
straighten. Upon straightening (or reducing the degree of
undulation), the selective expansion features 2150 provide enhanced
resistance to compression back from the expanded diameter. In
different terms, the more straight, and less undulating shape,
results in less perpendicular forces on the arrangement from
compression and instead achieve more oblique compression angles on
the selective expansion features 2150.
[0260] FIGS. 50-52 show alternative or additional selective
expansion features 2160 in the form of high arch, or omega-shaped
elements. These selective expansion features 2160 naturally resist
further compression at the initial, smaller diameter. In
particular, the selective expansion features 2160 also bottom out
or self-limit (e.g., the selective expansion features 2150 include
surfaces that engage each other) to inhibit further compression. As
shown, the bases of the arch shapes will come into contact to
arrest compression of the second frame element 2122. The relatively
long arc-length of the curvature of the arch-shape of the selective
expansion features 2160 may help spread stresses/strains over a
greater area, thereby helping resist fatigue effects. Additionally,
such distributed stress/strain profiles may assist with resisting
compression following diametric expansion by distributing strain
hardening across the apex of the arch-, or omega-shaped selective
expansion features 2160.
[0261] FIGS. 51-52 show additional variations of the selective
expansion features 2160. As shown, auxiliary expansion features
2170 may be coupled between portions of the selective expansion
features 2160. For example, auxiliary expansion features shaped
similarly to the selective expansion features 2150 (FIG. 51) and/or
the selective expansion features 2160 (FIG. 52) may be coupled to
the auxiliary expansion features 2170 (e.g., between the legs of
the arch shape). These auxiliary expansion features 2170 operate in
a similar manner to resist compression at the initial, smaller
diameter (e.g., by self-engaging), permit expansion to a larger
diameter (e.g., by deforming), and then resist compression at the
larger diameter (e.g., by straightening).
[0262] Inventive features of this disclosure have been described
above both generically and with regard to specific embodiments. It
will be apparent to those skilled in the art that various
modifications and variations can be made in the embodiments without
departing from the scope of the disclosure. Thus, it is intended
that the embodiments cover the modifications and variations of this
invention provided they come within the scope of the appended
claims and their equivalents.
* * * * *